FeverPhase 1NCT06855576

Bioequivalence Study of Paracetamol With Oral Single Dose Administration in Healthy Adult Subjects Under Fasting Conditions

A Phase 1 study testing Paracetamol ODT, Alvedon film-coated tablet and Panadol film-coated Tablet in people with Fever and Pain, run by HALEON at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study aims to evaluate the bioequivalence of new formulated orodispersible tablet (ODT) containing 500 milligram (mg) paracetamol in comparison to the European marketed Alvedon (paracetamol) 500 mg film-coated tablets and the Australian marketed Panadol (paracetamol) 500 mg film-coated tablets as reference… Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Fever, Pain
What is being tested?: Paracetamol ODT, Alvedon film-coated tablet and Panadol film-coated Tablet
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 54 participants
Where: 1 siteGermany
Study dates: 5 Mar 2025to 17 Apr 2025
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Written informed consent, after having been informed about benefits and potential risks of the clinical trial, as well as details of the insurance taken out to cover the participants participating in the clinical trial.
Sex: male/female.
Age: 18 to 55 years (including)
Body-mass index (BMI): more than or equal to (>=)18.5 kilogram per meter square (kg/m^2) and less than or equal to (<=) 30.0 kg/m^2.
Body weight: >= 50.0 kg for males and >= 45.0 kg for females.
Good state of health.

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Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Female participant of childbearing potential and at risk for pregnancy must agree to use a highly effective method of contraception throughout the study and for at least 7 days after the last dose of assigned treatment.
Non-smoker or ex-smoker for at least 3 months (including non-nicotine vapers, nicotine chewing gum or pouches or nicotine replacement therapy).

Who cannot join

Safety Concerns
Existing cardiac and/or haematological diseases or pathological findings, which might interfere with the safety or tolerability of the active ingredient.
Existing renal diseases or pathological findings, which might interfere with the safety or tolerability, and/or pharmacokinetics of the active ingredient.
Current evidence of ongoing hepatic disease or impaired hepatic function at screening. A participant will be excluded if more than one of the following lab value deviations are found: 1) Aspartate aminotransferase (AST) (>= 1.2 upper limit of normal [ULN]), Alanine transaminase (ALT) (>= 1.2 ULN), 2) Gamma-glutamyl transferase (GGT) (>= 1.2 ULN), Alkaline phosphatase (ALP) (>= 1.2 ULN), 3) total bilirubin (greater than [>] 2.00 milligrams per deciliter (mg/dL), except in case of existing Morbus Gilbert-Meulengracht deduced from anamnesis/medical history) or creatine kinase (>= 3 ULN), and creatinine > 0.1 mg/dL ULN (limit of > 0.1 mg/dL correspondents to of > 9 micromole per liter [μmol/l] ULN). A single deviation from the above values is acceptable and will not exclude the candidate, unless specifically advised by the investigator.
Existing gastrointestinal diseases or pathological findings, which might interfere with the safety, tolerability, absorption and/or pharmacokinetics of the active ingredient.
History of relevant central nervous system (CNS) and/or psychiatric disorders and/or currently treated CNS and/or psychiatric disorders.

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History or clinical evidence at screening of pancreatic injury or pancreatitis.
History of inflammatory bowel disease or gastrointestinal bleeding including peptic ulcers.
Diagnosis of systemic lupus erythematosus, thyroid diseases, secondary Raynaud's syndrome; known hyperkalemia.
Evidence of urinary obstruction (example, due to benign prostate hyperplasia) or difficulty in voiding at screening.
Status of glutathione depletion (eating disorder, cystic fibrosis, human immunodeficiency virus [HIV] infection, starvation, cachexia) due to metabolic deficiencies.
Oral surgery within 4 weeks of dosing, dental work or extractions within 2 weeks of dosing, or presence of any clinically significant (as determined by the principal investigator or designee) oral pathology including lesions, sores or inflammation.
History of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, bowel resection, gastric bypass, gastric stapling or gastric banding (note: this is not applicable for minor abdominal surgery without significant tissue resection, example, appendectomy and herniorrhaphy).
Participants, who report a frequent occurrence of migraine attacks.
Acute or chronic diseases which may interfere with the pharmacokinetics of the investigational medicinal product (IMP).
Clinically relevant chronic or acute infectious illnesses or febrile infections within two weeks prior to start of the study.
History or current evidence of renal disease or impaired renal function at screening as indicated by abnormal levels of serum creatinine (> 1.43 mg/dL) or blood urea nitrogen (BUN) (>= 35 mg/dL) or the presence of clinically significant abnormal urinary constituents (example, albuminuria).
Systolic blood pressure less than (<) 90 or > 139 millimeter of mercury (mmHg).
Diastolic blood pressure < 50 or > 89 mmHg.
Heart rate < 50 beats per minute (bpm) or > 90 bpm.
Corrected QT interval (QTc) interval > 450 milliseconds (ms) for men and > 470 ms for women.
Hemoglobin value < 12.0 grams per deciliter (g/dL) for males and < 11.5 g/dL for females.
Evidence or history of medication overuse headache, or allergic disease to medication within the last 5 years that may increase the risk associated with study participation.
Laboratory values out of normal range unless the deviation from normal is judged as not relevant for the clinical trial by the investigator.
Positive anti-HIV-test (if positive to be verified by western blot), hepatitis B surface antigen (HBs-AG) test and anti-hepatitis B core immunoglobulin M (HBc IgM) or anti-hepatitis C virus (HCV) test.
Known allergic reactions to the active ingredients used or to constituents of the pharmaceutical preparations.
Any history of asthma, urticaria, or other significant allergic diathesis or allergic reaction to any other pain reliever/fever reducer. Participant with uncomplicated seasonal allergic rhinitis can be accepted if expected allergy season is clearly outside enrollment/treatment period.
History of severe allergies or multiple drug allergies unless it is judged as not relevant for the clinical trial by the investigator.
Lack of suitability for the clinical trial
History of illegal or legal drug abuse within 1 year prior to screening or recreational use of soft drugs (such as marijuana, codeine) within 1 month or hard drugs (such as cocaine, phencyclidine [PCP], crack, any opioid derivatives such as heroin or fentanyl, and amphetamine derivatives) within 3 months prior to screening.
Positive alcohol, cotinine or drug test at screening examination.
History of alcohol abuse in the last 5 years or regular intake of alcoholic food or beverages of >= 24 gram (g) pure ethanol for men or >= 12 g pure ethanol for women per day.
Participants who are on a diet which could affect the pharmacokinetics of the active ingredient.
Regular intake of beverages or food containing xanthine derivatives or xanthine-related compounds (example, coffee, tea, caffeine-containing sodas and chocolate), equivalent to >= 500 milligram (mg) xanthine per day.
Performance of strenuous physical exercise (body building, high performance sports) from 2 weeks prior to admission and throughout the entire study.
Participant reports consumption of any drug metabolizing enzyme (example, Cytochrome P450 3A4 (CYP3A4) or other cytochrome P450 enzymes) inducing or inhibiting aliments, beverages or food supplements (example, broccoli, Brussels sprouts, grapefruit, grapefruit juice, star fruit, St. John's Wort and so on) within 2 weeks prior to admission to the unit.
Use of any systemic or topical medication (including over the counter [OTC] medications, herbal remedies, cannabidiol cosmetics and any anticholinergic medicines or other medicines that may cause dry mouth) within 2 weeks or within less than 10 times the elimination half-life of the respective drug (whichever is longer) before first scheduled study drug administration, or is anticipated to require any concomitant medication during that period or at any time throughout the study.
Any history of long-term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St John's Wort or other drugs that induce liver enzymes.
Any vaccination, including Coronavirus disease (COVID)-19 vaccine, within 14 days prior to the first dose.
Donation of plasma within 7 days prior to dosing or donation or loss of 500 milliliter (mL) or more of whole blood within 8 weeks prior to dosing.
Participation in a clinical trial in which they have tried an IMP, a medical device or a marketed medicinal product during the last 6 months prior to individual enrolment of the participant.
Simultaneous participation in another clinical trial with active ingredients, medical devices or marketed medicinal products.
For female participants with childbearing potential only
Positive pregnancy test at screening examination.
Pregnant or lactating women.
Female participants who do not agree to apply highly effective contraceptive methods.
Administrative reasons
Close affiliation with the sponsor or the investigational site; example, a close relative of the investigator, dependent person (example, employee of or student at the investigational site), employee of the sponsor or affiliates.
Participants who are unable to understand the written and verbal instructions, in particular regarding the risks and inconveniences they will be exposed to during their participation in the clinical trial.

Trial locations and contacts

1 site in 1 country.

Germany1 site

SocraTec R&D GmbH
Erfurt, Thuringia, 99084

Other trials in Germany

About this study

Official title: A Phase I, Randomised, Open Label, Single Center, Single Oral Dose, Three Treatment, Three Period, Three Sequence, Change-over Bioequivalence Study of Paracetamol Orodispersible Tablet 500 mg (Haleon) to Assess Bioequivalence With Alvedon 500 mg Film-Coated Tablet (Haleon, Sweden) and Panadol 500 mg Film-Coated Tablet (Haleon, Australia) in Healthy Adult Subjects Under Fasting Conditions

Read the detailed description

This will be a single center, open-label, randomized (order of treatments), balanced, 3-period, 3-sequence, single dose, change-over trial with oral administration under fasting conditions separated by a washout period of at least 72 hours. Fifty-four healthy participants of both sexes (27 male, 27 female) are intended to be randomized to obtain 42 evaluable participants. The investigational products will be administered in fasted state as single oral doses of 500 mg paracetamol tablet. 1 tablet of test and 1 film-coated tablet of reference 1 and 1 film-coated tablet of reference 2 will be administered in a cross-over manner. Blood sampling will be performed over 24-hour post dose in order to characterize pharmacokinetic parameters.

Conditions: Fever, Pain
Being tested: Paracetamol ODT, Alvedon film-coated tablet, Panadol film-coated Tablet
Medical subject headings: Fever, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Paracetamol ODTDrug
Experimental Paracetamol 500 mg ODT
Alvedon film-coated tabletDrug
Marketed Paracetamol 500 mg film-coated tablet
Panadol film-coated TabletDrug
Marketed Paracetamol 500 mg film-coated tablet

Study groups in NCT06855576
Study group	Role	What they receive
Test Product	Experimental	Participants will be randomly assigned as per cross-over design to receive oral administration of one paracetamol ODT (test product) on day 1 of period 1, one Alvedon film-coated tablet (reference product 1) on day 1 of period 2 and one Panadol film-coated tablet (reference product 2) on day 1 of period 3, each under fasting conditions. There will be at least 72 hours of washout between each period (no more than 7 days). Receives: Drug: Paracetamol ODT; Drug: Alvedon film-coated tablet; Drug: Panadol film-coated Tablet
Reference Product 1	Active comparator	Participants will be randomly assigned as per cross-over design to receive oral administration of one Alvedon film-coated tablet (reference product 1) on day 1 of period 1, one Panadol film-coated tablet (reference product 2) on day 1 of period 2 and one paracetamol ODT (test product) on day 1 of period 3, each under fasting conditions. There will be at least 72 hours of washout between each period (no more than 7 days). Receives: Drug: Paracetamol ODT; Drug: Alvedon film-coated tablet; Drug: Panadol film-coated Tablet
Reference Product 2	Active comparator	Participants will be randomly assigned as per cross-over design to receive oral administration of one Panadol film-coated tablet (reference product 2) on day 1 of period 1, and one paracetamol ODT (test product) on day 1 of period 2 and one Alvedon film-coated tablet (reference product 1) on day 1 of period 3, each under fasting conditions. There will be at least 72 hours of washout between each period (no more than 7 days). Receives: Drug: Paracetamol ODT; Drug: Alvedon film-coated tablet; Drug: Panadol film-coated Tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum Observed Concentration (Cmax) for Paracetamol ODT (Test) Versus (vs.) Paracetamol (Alvedon Film-coated Tablet) (Reference 1)
Cmax was defined as maximum observed post-dose plasma concentration for paracetamol. Blood samples were collected at indicated timepoints for the analysis of Cmax. Pharmacokinetic (PK) parameters were determined by non-compartmental analysis.
Measured: Within one hour prior to dosing, at 5, 10, 15, 20, 25, 30, 35, 40, 50, 60, 75, 90, 120, 150, 180 minutes and at 4, 5, 6, 8, 10, 12, 14, 16 and 24 hours following dosing in each treatment period
Area Under the Concentration vs. Time Curve From Dosing Time to the Last Measurement Time Point (AUC0-tlast) for Paracetamol ODT (Test) vs. Paracetamol (Alvedon Film-coated Tablet) (Reference 1)
AUC0-tlast was defined as area under the concentration vs. time curve from dosing time to the last measurement time point with a concentration value above the lower limit of quantitation, calculated by means of the linear up/log down method (linear trapezoidal rule for increases in concentration/logarithmic trapezoidal rule for decreases in concentrations). Blood samples were collected at indicated timepoints for the analysis of AUC0-tlast. PK parameters were determined by non-compartmental analysis.
Measured: Within one hour prior to dosing, at 5, 10, 15, 20, 25, 30, 35, 40, 50, 60, 75, 90, 120, 150, 180 minutes and at 4, 5, 6, 8, 10, 12, 14, 16 and 24 hours following dosing in each treatment period
Time to Reach Maximum Concentration (Tmax) for Paracetamol ODT (Test) vs. Paracetamol (Alvedon Film-coated Tablet) (Reference 1)
Blood samples were collected at indicated timepoints for the analysis of tmax. PK parameters were determined by non-compartmental analysis.
Measured: Within one hour prior to dosing, at 5, 10, 15, 20, 25, 30, 35, 40, 50, 60, 75, 90, 120, 150, 180 minutes and at 4, 5, 6, 8, 10, 12, 14, 16 and 24 hours following dosing in each treatment period
Cmax for Paracetamol ODT (Test) vs. Paracetamol (Panadol Film-coated Tablet) (Reference 2)
Cmax was defined as maximum observed post-dose plasma concentration for paracetamol. Blood samples were collected at indicated timepoints for the analysis of Cmax. PK parameters were determined by non-compartmental analysis.
Measured: Within one hour prior to dosing, at 5, 10, 15, 20, 25, 30, 35, 40, 50, 60, 75, 90, 120, 150, 180 minutes and at 4, 5, 6, 8, 10, 12, 14, 16 and 24 hours following dosing in each treatment period
AUC0-tlast for Paracetamol ODT (Test) vs. Paracetamol (Panadol Film-coated Tablet) (Reference 2)
AUC0-tlast was defined as area under the concentration vs. time curve from dosing time to the last measurement time point with a concentration value above the lower limit of quantitation, calculated by means of the linear up/log down method (linear trapezoidal rule for increases in concentration/logarithmic trapezoidal rule for decreases in concentrations. Blood samples were collected at indicated timepoints for the analysis of AUC0-tlast). PK parameters were determined by non-compartmental analysis.
Measured: Within one hour prior to dosing, at 5, 10, 15, 20, 25, 30, 35, 40, 50, 60, 75, 90, 120, 150, 180 minutes and at 4, 5, 6, 8, 10, 12, 14, 16 and 24 hours following dosing in each treatment period
Tmax for Paracetamol ODT (Test) vs. Paracetamol (Panadol Film-coated Tablet) (Reference 2)
Blood samples were collected at indicated timepoints for the analysis of tmax. PK parameters were determined by non-compartmental analysis.
Measured: Within one hour prior to dosing, at 5, 10, 15, 20, 25, 30, 35, 40, 50, 60, 75, 90, 120, 150, 180 minutes and at 4, 5, 6, 8, 10, 12, 14, 16 and 24 hours following dosing in each treatment period

Secondary outcomes (12)

Area Under the Plasma Concentration vs. Time Curve Calculated From Time Zero to Infinity [AUC (0-inf)] for Paracetamol ODT (Test)
AUC (0-inf) equal to(=) AUC0-tlast addition(+) AUCexpol, where AUCexpol = Clast/Lz, where Clast was observed concentration at the last time point with a concentration value above the lower limit of quantitation, directly taken from measured concentration values and Lz was apparent terminal elimination rate constant determined by log-linear regression(Lz); the regression generally involved at least 3 consecutive measurable concentrations that decreased over time. Blood samples were collected at indicated timepoints for the analysis of AUC (0-inf). PK parameters were determined by non-compartmental analysis.
Measured: Within one hour prior to dosing, at 5, 10, 15, 20, 25, 30, 35, 40, 50, 60, 75, 90, 120, 150, 180 minutes and at 4, 5, 6, 8, 10, 12, 14, 16 and 24 hours following dosing in each treatment period
AUC (0-inf) for Paracetamol (Alvedon Film-coated Tablet) (Reference 1)
AUC (0-inf)= AUC0-tlast + AUCexpol, where AUCexpol = Clast/Lz, where Clast was observed concentration at the last time point with a concentration value above the lower limit of quantitation, directly taken from measured concentration values and Lz was apparent terminal elimination rate constant determined by log-linear regression; the regression generally involved at least 3 consecutive measurable concentrations that decreased over time. Blood samples were collected at indicated timepoints for the analysis of AUC (0-inf). PK parameters were determined by non-compartmental analysis.
Measured: Within one hour prior to dosing, at 5, 10, 15, 20, 25, 30, 35, 40, 50, 60, 75, 90, 120, 150, 180 minutes and at 4, 5, 6, 8, 10, 12, 14, 16 and 24 hours following dosing in each treatment period
AUC (0-inf) for Paracetamol (Panadol Film-coated Tablet) (Reference 2)
AUC (0-inf)= AUC0-tlast + AUCexpol, where AUCexpol = Clast/Lz, where Clast was observed concentration at the last time point with a concentration value above the lower limit of quantitation, directly taken from measured concentration values and Lz was apparent terminal elimination rate constant determined by log-linear regression; the regression generally involved at least 3 consecutive measurable concentrations that decreased over time. Blood samples were collected at indicated timepoints for the analysis of AUC (0-inf). PK parameters were determined by non-compartmental analysis.
Measured: Within one hour prior to dosing, at 5, 10, 15, 20, 25, 30, 35, 40, 50, 60, 75, 90, 120, 150, 180 minutes and at 4, 5, 6, 8, 10, 12, 14, 16 and 24 hours following dosing in each treatment period
AUCexpol% for Paracetamol ODT (Test)
AUCexpol%= AUCexpol multiplied by (*)100/AUC0-inf, where AUCexpol = Clast/Lz. Blood samples were collected at indicated timepoints for the analysis of AUCexpol%. PK parameters were determined by non-compartmental analysis.
Measured: Within one hour prior to dosing, at 5, 10, 15, 20, 25, 30, 35, 40, 50, 60, 75, 90, 120, 150, 180 minutes and at 4, 5, 6, 8, 10, 12, 14, 16 and 24 hours following dosing in each treatment period
AUCexpol% for Paracetamol (Alvedon Film-coated Tablet) (Reference 1)
AUCexpol%= AUCexpol*100/AUC0-inf, where AUCexpol = Clast/Lz. Blood samples were collected at indicated timepoints for the analysis of AUCexpol%. PK parameters were determined by non-compartmental analysis.
Measured: Within one hour prior to dosing, at 5, 10, 15, 20, 25, 30, 35, 40, 50, 60, 75, 90, 120, 150, 180 minutes and at 4, 5, 6, 8, 10, 12, 14, 16 and 24 hours following dosing in each treatment period
AUCexpol% for Paracetamol (Panadol Film-coated Tablet) (Reference 2)
AUCexpol%= AUCexpol*100/AUC0-inf, where AUCexpol = Clast/Lz. Blood samples were collected at indicated timepoints for the analysis of AUCexpol%. PK parameters were determined by non-compartmental analysis.
Measured: Within one hour prior to dosing, at 5, 10, 15, 20, 25, 30, 35, 40, 50, 60, 75, 90, 120, 150, 180 minutes and at 4, 5, 6, 8, 10, 12, 14, 16 and 24 hours following dosing in each treatment period
Lz for Paracetamol ODT (Test)
Lz was an apparent terminal elimination rate constant determined by log-linear regression; the regression generally involved at least 3 consecutive measurable concentrations that decreased over time. Blood samples were collected at indicated timepoints for the analysis of Lz. PK parameters were determined by non-compartmental analysis.
Measured: Within one hour prior to dosing, at 5, 10, 15, 20, 25, 30, 35, 40, 50, 60, 75, 90, 120, 150, 180 minutes and at 4, 5, 6, 8, 10, 12, 14, 16 and 24 hours following dosing in each treatment period
Lz for Paracetamol (Alvedon Film-coated Tablet) (Reference 1)
Lz was an apparent terminal elimination rate constant determined by log-linear regression; the regression generally involved at least 3 consecutive measurable concentrations that decreased over time. Blood samples were collected at indicated timepoints for the analysis of Lz. PK parameters were determined by non-compartmental analysis.
Measured: Within one hour prior to dosing, at 5, 10, 15, 20, 25, 30, 35, 40, 50, 60, 75, 90, 120, 150, 180 minutes and at 4, 5, 6, 8, 10, 12, 14, 16 and 24 hours following dosing in each treatment period
Lz for Paracetamol (Panadol Film-coated Tablet) (Reference 2)
Lz was an apparent terminal elimination rate constant determined by log-linear regression; the regression generally involved at least 3 consecutive measurable concentrations that decreased over time. Blood samples were collected at indicated timepoints for the analysis of Lz. PK parameters were determined by non-compartmental analysis.
Measured: Within one hour prior to dosing, at 5, 10, 15, 20, 25, 30, 35, 40, 50, 60, 75, 90, 120, 150, 180 minutes and at 4, 5, 6, 8, 10, 12, 14, 16 and 24 hours following dosing in each treatment period
Apparent Terminal Elimination Half-life (t1/2) for Paracetamol ODT (Test)
t1/2 = ln(2) / Lz. Blood samples were collected at indicated timepoints for the analysis of t1/2. PK parameters were determined by non-compartmental analysis.
Measured: Within one hour prior to dosing, at 5, 10, 15, 20, 25, 30, 35, 40, 50, 60, 75, 90, 120, 150, 180 minutes and at 4, 5, 6, 8, 10, 12, 14, 16 and 24 hours following dosing in each treatment period
t1/2 for Paracetamol (Alvedon Film-coated Tablet) (Reference 1)
t1/2 = ln(2) / Lz. Blood samples were collected at indicated timepoints for the analysis of t1/2. PK parameters were determined by non-compartmental analysis.
Measured: Within one hour prior to dosing, at 5, 10, 15, 20, 25, 30, 35, 40, 50, 60, 75, 90, 120, 150, 180 minutes and at 4, 5, 6, 8, 10, 12, 14, 16 and 24 hours following dosing in each treatment period
t1/2 for Paracetamol (Panadol Film-coated Tablet) (Reference 2)
t1/2 = ln(2) / Lz. Blood samples were collected at indicated timepoints for the analysis of t1/2. PK parameters were determined by non-compartmental analysis.
Measured: Within one hour prior to dosing, at 5, 10, 15, 20, 25, 30, 35, 40, 50, 60, 75, 90, 120, 150, 180 minutes and at 4, 5, 6, 8, 10, 12, 14, 16 and 24 hours following dosing in each treatment period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Mar 202517 Apr 2025

First posted4 Mar 2025
Study start5 Mar 2025
Primary completion17 Apr 2025
Study completion17 Apr 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for FeverStudies of the same condition, open and under way.
More trials run by HALEONThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 54 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06855576
Sponsor's protocol ID: 300141
Other IDs: 2024-514198-23-00
Status last verified: Jun 2026
First submitted: 28 Feb 2025
Last updated: 1 Jul 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Anonymized individual participant data and study documents can be requested for further research from ww.clinical-trialregister@haleon.com.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I, Randomised, Open Label, Single Center, Single Oral Dose, Three Treatment, Three Period, Three Sequence, Change-over Bioequivalence Study of Paracetamol Orodispersible Tablet 500 mg (Haleon) to Assess Bioequivalence With Alvedon 500 mg Film-Coated Tablet (Haleon, Sweden) and Panadol 500 mg Film-Coated Tablet (Haleon, Australia) in Healthy Adult Subjects Under Fasting Conditions
ClinicalTrials.gov ID: NCT06855576
Acronym / sponsor ID: 300141
Conditions: Fever, Pain
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 54 participants (actual)
Lead sponsor: HALEONIndustry (pharma, biotech, devices)
Study start: 5 Mar 2025 (actual)
Primary completion: 17 Apr 2025 (actual)
Study completion: 17 Apr 2025 (actual)
First posted: 4 Mar 2025 (actual)
Results: Posted 1 Jul 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Test Product	Experimental	Drug: Paracetamol ODT, Drug: Alvedon film-coated tablet, Drug: Panadol film-coated TabletParticipants will be randomly assigned as per cross-over design to receive oral administration of one paracetamol ODT (test product) on day 1 of period 1, one Alvedon film-coated tablet (reference product 1) on day 1 of period 2 and one Panadol film-coated tablet (reference product 2) on day 1 of period 3, each under fasting conditions. There will be at least 72 hours of washout between each period (no more than 7 days).
Reference Product 1	Active comparator	Drug: Paracetamol ODT, Drug: Alvedon film-coated tablet, Drug: Panadol film-coated TabletParticipants will be randomly assigned as per cross-over design to receive oral administration of one Alvedon film-coated tablet (reference product 1) on day 1 of period 1, one Panadol film-coated tablet (reference product 2) on day 1 of period 2 and one paracetamol ODT (test product) on day 1 of period 3, each under fasting conditions. There will be at least 72 hours of washout between each period (no more than 7 days).
Reference Product 2	Active comparator	Drug: Paracetamol ODT, Drug: Alvedon film-coated tablet, Drug: Panadol film-coated TabletParticipants will be randomly assigned as per cross-over design to receive oral administration of one Panadol film-coated tablet (reference product 2) on day 1 of period 1, and one paracetamol ODT (test product) on day 1 of period 2 and one Alvedon film-coated tablet (reference product 1) on day 1 of period 3, each under fasting conditions. There will be at least 72 hours of washout between each period (no more than 7 days).

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (9 listed)

Written informed consent, after having been informed about benefits and potential risks of the clinical trial, as well as details of the insurance taken out to cover the participants participating in the clinical trial.
Sex: male/female.
Age: 18 to 55 years (including)
Body-mass index (BMI): more than or equal to (>=)18.5 kilogram per meter square (kg/m^2) and less than or equal to (<=) 30.0 kg/m^2.
Body weight: >= 50.0 kg for males and >= 45.0 kg for females.

Key exclusion criteria (49 listed)

Safety Concerns
Lack of suitability for the clinical trial
For female participants with childbearing potential only
Administrative reasons

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Paracetamol ODTExperimental Paracetamol 500 mg ODT	Drug	Reference Product 1, Reference Product 2, Test Product
Alvedon film-coated tabletMarketed Paracetamol 500 mg film-coated tablet	Drug	Reference Product 1, Reference Product 2, Test Product
Panadol film-coated TabletMarketed Paracetamol 500 mg film-coated tablet	Drug	Reference Product 1, Reference Product 2, Test Product

Primary outcome

Maximum Observed Concentration (Cmax) for Paracetamol ODT (Test) Versus (vs.) Paracetamol (Alvedon Film-coated Tablet) (Reference 1)
Time frame: Within one hour prior to dosing, at 5, 10, 15, 20, 25, 30, 35, 40, 50, 60, 75, 90, 120, 150, 180 minutes and at 4, 5, 6, 8, 10, 12, 14, 16 and 24 hours following dosing in each treatment period
Cmax was defined as maximum observed post-dose plasma concentration for paracetamol. Blood samples were collected at indicated timepoints for the analysis of Cmax. Pharmacokinetic (PK) parameters were determined by non-compartmental analysis.
Area Under the Concentration vs. Time Curve From Dosing Time to the Last Measurement Time Point (AUC0-tlast) for Paracetamol ODT (Test) vs. Paracetamol (Alvedon Film-coated Tablet) (Reference 1)
Time frame: Within one hour prior to dosing, at 5, 10, 15, 20, 25, 30, 35, 40, 50, 60, 75, 90, 120, 150, 180 minutes and at 4, 5, 6, 8, 10, 12, 14, 16 and 24 hours following dosing in each treatment period
AUC0-tlast was defined as area under the concentration vs. time curve from dosing time to the last measurement time point with a concentration value above the lower limit of quantitation, calculated by means of the linear up/log down method (linear trapezoidal rule for increases in concentration/logarithmic trapezoidal rule for decreases in concentrations). Blood samples were collected at indicated timepoints for the analysis of AUC0-tlast. PK parameters were determined by non-compartmental analysis.
Time to Reach Maximum Concentration (Tmax) for Paracetamol ODT (Test) vs. Paracetamol (Alvedon Film-coated Tablet) (Reference 1)
Time frame: Within one hour prior to dosing, at 5, 10, 15, 20, 25, 30, 35, 40, 50, 60, 75, 90, 120, 150, 180 minutes and at 4, 5, 6, 8, 10, 12, 14, 16 and 24 hours following dosing in each treatment period
Blood samples were collected at indicated timepoints for the analysis of tmax. PK parameters were determined by non-compartmental analysis.
Cmax for Paracetamol ODT (Test) vs. Paracetamol (Panadol Film-coated Tablet) (Reference 2)
Time frame: Within one hour prior to dosing, at 5, 10, 15, 20, 25, 30, 35, 40, 50, 60, 75, 90, 120, 150, 180 minutes and at 4, 5, 6, 8, 10, 12, 14, 16 and 24 hours following dosing in each treatment period
Cmax was defined as maximum observed post-dose plasma concentration for paracetamol. Blood samples were collected at indicated timepoints for the analysis of Cmax. PK parameters were determined by non-compartmental analysis.
AUC0-tlast for Paracetamol ODT (Test) vs. Paracetamol (Panadol Film-coated Tablet) (Reference 2)
Time frame: Within one hour prior to dosing, at 5, 10, 15, 20, 25, 30, 35, 40, 50, 60, 75, 90, 120, 150, 180 minutes and at 4, 5, 6, 8, 10, 12, 14, 16 and 24 hours following dosing in each treatment period
AUC0-tlast was defined as area under the concentration vs. time curve from dosing time to the last measurement time point with a concentration value above the lower limit of quantitation, calculated by means of the linear up/log down method (linear trapezoidal rule for increases in concentration/logarithmic trapezoidal rule for decreases in concentrations. Blood samples were collected at indicated timepoints for the analysis of AUC0-tlast). PK parameters were determined by non-compartmental analysis.
Tmax for Paracetamol ODT (Test) vs. Paracetamol (Panadol Film-coated Tablet) (Reference 2)
Time frame: Within one hour prior to dosing, at 5, 10, 15, 20, 25, 30, 35, 40, 50, 60, 75, 90, 120, 150, 180 minutes and at 4, 5, 6, 8, 10, 12, 14, 16 and 24 hours following dosing in each treatment period
Blood samples were collected at indicated timepoints for the analysis of tmax. PK parameters were determined by non-compartmental analysis.

12 secondary outcomes

Area Under the Plasma Concentration vs. Time Curve Calculated From Time Zero to Infinity [AUC (0-inf)] for Paracetamol ODT (Test)
Time frame: Within one hour prior to dosing, at 5, 10, 15, 20, 25, 30, 35, 40, 50, 60, 75, 90, 120, 150, 180 minutes and at 4, 5, 6, 8, 10, 12, 14, 16 and 24 hours following dosing in each treatment period
AUC (0-inf) for Paracetamol (Alvedon Film-coated Tablet) (Reference 1)
Time frame: Within one hour prior to dosing, at 5, 10, 15, 20, 25, 30, 35, 40, 50, 60, 75, 90, 120, 150, 180 minutes and at 4, 5, 6, 8, 10, 12, 14, 16 and 24 hours following dosing in each treatment period
AUC (0-inf) for Paracetamol (Panadol Film-coated Tablet) (Reference 2)
Time frame: Within one hour prior to dosing, at 5, 10, 15, 20, 25, 30, 35, 40, 50, 60, 75, 90, 120, 150, 180 minutes and at 4, 5, 6, 8, 10, 12, 14, 16 and 24 hours following dosing in each treatment period
AUCexpol% for Paracetamol ODT (Test)
Time frame: Within one hour prior to dosing, at 5, 10, 15, 20, 25, 30, 35, 40, 50, 60, 75, 90, 120, 150, 180 minutes and at 4, 5, 6, 8, 10, 12, 14, 16 and 24 hours following dosing in each treatment period
AUCexpol% for Paracetamol (Alvedon Film-coated Tablet) (Reference 1)
Time frame: Within one hour prior to dosing, at 5, 10, 15, 20, 25, 30, 35, 40, 50, 60, 75, 90, 120, 150, 180 minutes and at 4, 5, 6, 8, 10, 12, 14, 16 and 24 hours following dosing in each treatment period
AUCexpol% for Paracetamol (Panadol Film-coated Tablet) (Reference 2)
Time frame: Within one hour prior to dosing, at 5, 10, 15, 20, 25, 30, 35, 40, 50, 60, 75, 90, 120, 150, 180 minutes and at 4, 5, 6, 8, 10, 12, 14, 16 and 24 hours following dosing in each treatment period
Lz for Paracetamol ODT (Test)
Time frame: Within one hour prior to dosing, at 5, 10, 15, 20, 25, 30, 35, 40, 50, 60, 75, 90, 120, 150, 180 minutes and at 4, 5, 6, 8, 10, 12, 14, 16 and 24 hours following dosing in each treatment period
Lz for Paracetamol (Alvedon Film-coated Tablet) (Reference 1)
Time frame: Within one hour prior to dosing, at 5, 10, 15, 20, 25, 30, 35, 40, 50, 60, 75, 90, 120, 150, 180 minutes and at 4, 5, 6, 8, 10, 12, 14, 16 and 24 hours following dosing in each treatment period
Lz for Paracetamol (Panadol Film-coated Tablet) (Reference 2)
Time frame: Within one hour prior to dosing, at 5, 10, 15, 20, 25, 30, 35, 40, 50, 60, 75, 90, 120, 150, 180 minutes and at 4, 5, 6, 8, 10, 12, 14, 16 and 24 hours following dosing in each treatment period
Apparent Terminal Elimination Half-life (t1/2) for Paracetamol ODT (Test)
Time frame: Within one hour prior to dosing, at 5, 10, 15, 20, 25, 30, 35, 40, 50, 60, 75, 90, 120, 150, 180 minutes and at 4, 5, 6, 8, 10, 12, 14, 16 and 24 hours following dosing in each treatment period
t1/2 for Paracetamol (Alvedon Film-coated Tablet) (Reference 1)
Time frame: Within one hour prior to dosing, at 5, 10, 15, 20, 25, 30, 35, 40, 50, 60, 75, 90, 120, 150, 180 minutes and at 4, 5, 6, 8, 10, 12, 14, 16 and 24 hours following dosing in each treatment period
t1/2 for Paracetamol (Panadol Film-coated Tablet) (Reference 2)
Time frame: Within one hour prior to dosing, at 5, 10, 15, 20, 25, 30, 35, 40, 50, 60, 75, 90, 120, 150, 180 minutes and at 4, 5, 6, 8, 10, 12, 14, 16 and 24 hours following dosing in each treatment period

Results and safety

Results posted to the registry on 1 Jul 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Test Product/ Reference Product 2/ Reference Product 1	18	18
Reference Product 1/ Test Product/ Reference Product 2	18	18
Reference Product 2/ Reference Product 1/ Test Product	18	18

Primary outcome: Maximum Observed Concentration (Cmax) for Paracetamol ODT (Test) Versus (vs.) Paracetamol (Alvedon Film-coated Tablet) (Reference 1)

Time frame: Within one hour prior to dosing, at 5, 10, 15, 20, 25, 30, 35, 40, 50, 60, 75, 90, 120, 150, 180 minutes and at 4, 5, 6, 8, 10, 12, 14, 16 and 24 hours following dosing in each treatment period. Geometric mean (Geometric Coefficient of Variation). Unit: micrograms per milliliter(µg/mL)

Measure	Test Product n = 53	Reference Product 1 n = 51
Value	6.27 (36.8)	7.71 (53.6)

Test Product vs Reference Product 1: Ratio of Geometric Least Square Mean: 82.22 (90% CI 76.12 to 88.8)

Population analysed: The PKAS (pharmacokinetics analysis set) was defined as all participants in the PK population who completed at least two periods with one test formulation and who had no major protocol deviations concerning pharmacokinetics. The PK population was defined as all randomised participants who had at least one measurable PK parameter. Only those participants with data available at the specified timepoint were analyzed.

Primary outcome: Area Under the Concentration vs. Time Curve From Dosing Time to the Last Measurement Time Point (AUC0-tlast) for Paracetamol ODT (Test) vs. Paracetamol (Alvedon Film-coated Tablet) (Reference 1)

Measure	Test Product n = 53	Reference Product 1 n = 51
Value	23.9 (36.6)	24.3 (37.8)

Test Product vs Reference Product 1: Ratio of Geometric Least Square Mean: 99.23 (90% CI 97.54 to 100.94)

Population analysed: PKAS Population. Only those participants with data available at the specified timepoint were analyzed.

Primary outcome: Time to Reach Maximum Concentration (Tmax) for Paracetamol ODT (Test) vs. Paracetamol (Alvedon Film-coated Tablet) (Reference 1)

Measure	Test Product n = 53	Reference Product 1 n = 51
Value	1.00 (0.420 to 2.00)	0.670 (0.250 to 2.52)

Test Product vs Reference Product 1: Ratio of the Medians: 149.25

Population analysed: PKAS Population. Only those participants with data available at the specified timepoint were analyzed.

Primary outcome: Cmax for Paracetamol ODT (Test) vs. Paracetamol (Panadol Film-coated Tablet) (Reference 2)

Measure	Test Product n = 53	Reference Product 2 n = 53
Value	6.27 (36.8)	8.41 (48.6)

Test Product vs Reference Product 2: Ratio of Geometric Least Square Mean: 74.82 (90% CI 68.49 to 81.73)

Population analysed: PKAS Population. Only those participants with data available at the specified timepoint were analyzed.

12 secondary outcomes are reported in the full results.

Adverse events

Time frame: Immediately after a participant provided consent to participate in the study up to day 2 of period 3 (Approximately up to 32 days).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Test Product	0 of 53 (0%)	12 of 53 (22.6%)	0 of 53
Reference Product 1	0 of 53 (0%)	16 of 53 (30.2%)	0 of 53
Reference Product 2	0 of 53 (0%)	9 of 53 (17%)	0 of 53

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. Anonymized individual participant data and study documents can be requested for further research from ww.clinical-trialregister@haleon.com.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Paracetamol ODT, Alvedon film-coated tablet and Panadol film-coated Tablet in people with Fever and Pain, run by HALEON at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 49 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Observed Concentration (Cmax) for Paracetamol ODT (Test) Versus (vs.) Paracetamol (Alvedon Film-coated Tablet) (Reference 1) (time frame: Within one hour prior to dosing, at 5, 10, 15, 20, 25, 30, 35, 40, 50, 60, 75, 90, 120, 150, 180 minutes and at 4, 5, 6, 8, 10, 12, 14, 16 and 24 hours following dosing in each treatment period). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06855576.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026; AzTrials last refreshed its copy on 7 Nov 2026.