PainPhase 1NCT05737069
A Bioequivalence Study of Two Ibuprofen Arginine Granules 400 mg Formulations Under Fasting and Fed Conditions in Chinese Healthy Adult Subjects
A Phase 1 study testing Ibuprofen arginine granules 400 mg and Ibuprofen arginine granules 400 mg (Spedifen) in people with Pain, run by HALEON at 1 site in China.
Trial summary
The primary purpose of this study is to demonstrate the bioequivalence of two ibuprofen arginine granules 400 milligram (mg) formulations under fasting and fed conditions in Chinese healthy adult participants. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Ibuprofen arginine granules 400 mg and Ibuprofen arginine granules 400 mg (Spedifen)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteChina
- Study dates
- 19 Apr 2023to 15 May 2023
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants provision of a signed and dated informed consent and/or assent document indicating that the participant has been informed of all pertinent aspects of the study before any assessment is performed.
- Participants who is willing and able to comply with scheduled visits, treatment plan, laboratory tests, study restrictions, lifestyle considerations and other study procedures.
- Healthy Participants, which is defined as in general good physical health, as judged by the investigator and no clinically significant relevant abnormalities identified by a detailed medical history, full physical examination, including vital signs, 12-lead electrocardiogram (ECG) and laboratory tests.
- A Participants with a Body Mass Index (BMI) of 19-26 kilogram per meter square (kg/m^2) (including 19, excluding 26) [BMI equal to (=) weight (Kilogram [kg])/height^2 (m^2)]; and a total body weight more than or equal to >= 50 kilogram (kg) for males, and >= 45 kg for females, at screening.
- Participants with one negative polymerase chain reaction (PCR) or antigen test (on Day-1) for active Coronavirus disease 2019 (COVID-19).
- Participants of childbearing potential and are sexually active and at risk for pregnancy must agree to use a highly effective method of contraception throughout the study and for at least 30 days after the last dose of assigned treatment. Female participant who are not of childbearing potential must meet requirements in the Contraception section of protocol.
Who cannot join
- Known or suspected intolerance or hypersensitivity or photosensitivity to the investigational products (or closely related compounds) or any of their stated ingredients.
- Allergy to skin disinfecting agents, tape, or latex rubber, whenever appropriate substitutions cannot be applied or in the investigator's opinion may pose a risk to the candidate.
- Diagnosis of long QT syndrome or QTcF > 450 millisecond (msec) at screening.
- Clinically significant vital sign abnormalities (systolic blood pressure lower than 90 or over 140 millimeters of mercury (mmHg), diastolic blood pressure lower than 60 or over 90 mmHg, or pulse rate less than 50 or over 100 beats per minute [bpm]).
- Use of any medication (including over-the-counter medications and Chinese herbal and traditional remedies) within 2 weeks before first scheduled study drug administration or within less than 10 times the elimination half-life of the concomitant medication (whichever is longer) or is anticipated to require any concomitant medication during that period or at any time throughout the study. Allowed treatments are:
- systemic contraceptives and hormone replacement therapy, as long as female participant is on stable treatment for at least 3 months before first scheduled study drug administration and continues treatment throughout the study.
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- occasional use of acetaminophen (up to 2 grams [g] in 24 hours).
- Participants has a history of drug abuse or has positive urine drug abuse screening at screening or on Day-1.
- Participants reported regular consumption of > 5 cups (1 cup approximately 250 milliliters [mL]) of coffee or tea per day (or equivalent consumption of >= 500 mg caffeine per day using other products). Or consuming any beverages or food containing caffeine, such as coffee, tea, coke, chocolate, etc., within 48 hours prior to screening.
- Smoking or history of regular use of tobacco- or nicotine-containing products (for example nicotine patch, electronic cigarette) within 6 months prior to screening. Or a participant who is unwilling to abstain from tobacco or nicotine containing product use during the study.
- Evidence, as reported by an alcohol breath testing, for current alcohol abuse or reports a regular average alcohol consumption exceeding 18 g (women) or 35 g (men) of pure alcohol per day, that is (i.e.) 1 drink/day for women or 2 drinks/day for men [1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor] within 6 months prior to screening.
- Participation in other clinical trials involving investigational drug(s) within 90 days prior to screening.
- Those who have blood donation (including component donation) or blood loss >= 400 mL within 3 months before the study or have blood transfusion; those who have blood donation (including component donation) or blood loss >= 200 mL within 1 month before the study (except female physiological blood loss).
- Acute or chronic medical condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study. Or any condition not identified in the protocol that in the opinion of the investigator would confound the evaluation and interpretation of the study data or may put the participant at risk.
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease within the last 5 years that may increase the risk associated with study participation.
- Clinically relevant chronic or acute infectious illnesses or febrile infections within two weeks prior to start of the study.
- Participation with known COVID-19 positive contacts in the past 14 days.
- Participation with signs or symptoms highly suggestive of COVID-19 (including not limited to fever, cough, chills, new loss of taste or smell, etc.) that also align with the clinical judgement of the investigator, within 14 days of inpatient admission as defined by World Health Organization (WHO) or local guidance.
- Any vaccination, including COVID-19 vaccine, within 14 days prior to the first dose of investigational products.
- Any surgical or medical condition which may significantly alter the absorption, distribution, metabolism or excretion of any drug substance but not limited to any of the following:
- 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, e.g., appendectomy and herniorrhaphy).
- History of inflammatory bowel disease.
- History or current evidence of renal disease or impaired renal function at screening as indicated by abnormal levels of estimated glomerular filtration rate (eGFR) less than (<) 90 mL/min/1.73m^2 or the presence of clinically significant abnormal urinary constituents (e.g., albuminuria).
- History or current evidence of ongoing hepatic disease or impaired hepatic function at screening. A candidate will be excluded if more than one of the following lab value deviations are found:
- Aspartate aminotransferase (AST) (>= 1.2 upper limit of normal [ULN]), alanine transaminase (ALT) (>= 1.2 ULN),
- Gamma-glutamyl transferase (GGT) (>= 1.2 ULN), alkaline phosphatase (ALP) (>= 1.2 ULN),
- Bilirubin (>= 1.5 ULN) or creatine kinase (CK) (>= 3 ULN). A single deviation from the above values is acceptable and will not exclude the candidate, unless specifically advised by the investigator.
- Evidence of urinary obstruction or difficulty in voiding at screening.
- History or clinical evidence at screening of pancreatic injury or pancreatitis.
- Pregnant or lactating women, or participant intending to become pregnant over the duration of the study.
- Positive results (or out of normal range) any of the virology tests for hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antibody or syphilis.
- Participants reports consumption of any drug metabolizing enzyme (for example (e.g.), CYP3A4 or other cytochrome P450 enzymes) inducing or inhibiting aliments, beverages or food supplements (e.g., broccoli, Brussels sprouts, grapefruit, grapefruit juice, star fruit, St. John's Wort etc.) within 2 weeks prior to screening until admission to the unit.
- Performance of strenuous physical exercise (body building, high performance sports) from 2 weeks prior to admission.
- Those who are not suitable for participation in this study as determined by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-label, Single-center, Single-dose, Two Treatment, Two-sequence, Two-period, Two-cohort, Two-way Crossover Bioequivalence Study of Two Ibuprofen Arginine Granules 400 mg Formulations Under Fasting and Fed Conditions in Chinese Healthy Adult Subjects
The primary purpose of this study is to demonstrate the bioequivalence of two ibuprofen arginine granules 400 milligram (mg) formulations under fasting and fed conditions in Chinese healthy adult participants. The secondary purpose of this study is to assess the pharmacokinetic and safety profile of the test and reference preparations.
Read the detailed description
The bioequivalence study adopts a single-center, randomized, open-label, single-dose, two-treatment, two-sequence, two-period, two-cohort, two-way crossover design with at least 2-day washout period, under both fasting and fed conditions in Chinese healthy adult participants. It will be planned to enroll approximately 84 participants out of which the first 34 participants for the fasted cohort and the subsequent 50 participants for the fed cohort receiving ibuprofen arginine granules 400 mg. Participants will be randomly assigned to either one of the 2 treatment (Test or Reference product) sequences in a 1:1 ratio within fasted cohort and fed cohort.
- Conditions
- Pain
- Being tested
- Ibuprofen arginine granules 400 mg, Ibuprofen arginine granules 400 mg (Spedifen)
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ibuprofen arginine granules 400 mgDrug
Experimental- Ibuprofen arginine granules 400 mg, one sachet administration containing 400 mg ibuprofen granules.
Ibuprofen arginine granules 400 mg (Spedifen)Drug
Marketed drug- Ibuprofen arginine granules 400 mg (Spedifen), one sachet administration containing 400 mg ibuprofen granules.
| Study group | Role | What they receive |
|---|---|---|
| Ibuprofen arginine granules 400 mg | Experimental | Participants will be randomly assigned as per cross-over design to receive one sachet of Ibuprofen arginine granules 400 mg (test product) on day 1 of period 1 and will receive one sachet of Ibuprofen arginine granules 400 mg (Spedifen) (reference product) on day 1 of period 2 with at least 2 days washout period. Participants will be instructed to consume the product orally by dissolving it in 240 mL of warm water. Receives: Drug: Ibuprofen arginine granules 400 mg; Drug: Ibuprofen arginine granules 400 mg (Spedifen) |
| Ibuprofen arginine granules 400 mg (Spedifen) | Active comparator | Participants will be randomly assigned as per cross-over design to receive one sachet of Ibuprofen arginine granules 400 mg (Spedifen) (reference product) on day 1 of period 1 and will receive one sachet of Ibuprofen arginine granules 400 mg (test product) on day 1 of period 2 with at least 2 days washout period. Participants will be instructed to consume the product orally by dissolving it in 240 mL of warm water. Receives: Drug: Ibuprofen arginine granules 400 mg; Drug: Ibuprofen arginine granules 400 mg (Spedifen) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Plasma Concentration Time Curve From Time Zero to Last Observed Concentration at Time t (AUC[0-t]) for Ibuprofen in Fasted Conditions
AUC(0-t) was defined as area under the plasma concentration-time curve from time zero to last observed concentration at time t calculated using the linear up log down trapezoidal rule. Blood samples were collected at indicated timepoints for the analysis of AUC(0-t). Pharmacokinetic (PK) parameters were determined by non-compartmental analysis.
Measured: Pre-dose (within 2 hours prior to dosing) and at 5, 10, 15, 20, 30, 45, 60, 75, 90, 105, 120 minutes, 2.5, 3, 4, 6, 8, and 12 hours post-dose
Area Under the Plasma Concentration Time Curve From Time Zero to Time Infinity (AUC [0-inf]) for Ibuprofen in Fasted Conditions
AUC (0-inf) was defined as area under the plasma concentration versus time curve calculated from time 0 to infinity, computed as AUC(0-inf) = AUC(0-t) +Ct/λz where Ct was the plasma concentration at the last measurable sampling time point and λz was the terminal elimination rate constant. Blood samples were collected at indicated timepoints for the analysis of AUC(0-inf). PK parameters were determined by non-compartmental analysis.
Measured: Pre-dose (within 2 hours prior to dosing) and at 5, 10, 15, 20, 30, 45, 60, 75, 90, 105, 120 minutes, 2.5, 3, 4, 6, 8, and 12 hours post-dose
Observed Maximum Plasma Concentration (Cmax) for Ibuprofen in Fasted Conditions
Cmax was defined as maximum observed post-dose plasma concentration for ibuprofen. Blood samples were collected at indicated timepoints for the analysis of Cmax. PK parameters were determined by non-compartmental analysis.
Measured: Pre-dose (within 2 hours prior to dosing) and at 5, 10, 15, 20, 30, 45, 60, 75, 90, 105, 120 minutes, 2.5, 3, 4, 6, 8, and 12 hours post-dose
AUC(0-t) for Ibuprofen in Fed Conditions
AUC(0-t) was defined as area under the plasma concentration-time curve from time zero to last observed concentration at time t calculated using the linear up log down trapezoidal rule. Blood samples were collected at indicated timepoints for the analysis of AUC(0-t). PK parameters were determined by non-compartmental analysis.
Measured: Pre-dose (within 2 hours prior to dosing) and 10, 30, 45, 60, 75, 90, 120 minutes, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10 and 12 hours post-dose
AUC (0-inf) for Ibuprofen in Fed Conditions
AUC (0-inf) was defined as area under the plasma concentration versus time curve calculated from time 0 to infinity, computed as AUC(0-inf) = AUC(0-t) +Ct/λz where Ct was the plasma concentration at the last measurable sampling time point and λz was the terminal elimination rate constant. Blood samples were collected at indicated timepoints for the analysis of AUC(0-inf). PK parameters were determined by non-compartmental analysis.
Measured: Pre-dose (within 2 hours prior to dosing) and 10, 30, 45, 60, 75, 90, 120 minutes, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10 and 12 hours post-dose
Cmax for Ibuprofen in Fed Conditions
Cmax was defined as maximum observed post-dose plasma concentration for ibuprofen. Blood samples were collected at indicated timepoints for the analysis of Cmax. PK parameters were determined by non-compartmental analysis.
Measured: Pre-dose (within 2 hours prior to dosing) and 10, 30, 45, 60, 75, 90, 120 minutes, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10 and 12 hours post-dose
Secondary outcomes (8)
Time to Reach Maximum Plasma Concentration (Tmax) of Ibuprofen in Fasted Conditions
Blood samples were collected at indicated timepoints for the analysis of Tmax. PK parameters were determined by non-compartmental analysis.
Measured: Pre-dose (within 2 hours prior to dosing) and at 5, 10, 15, 20, 30, 45, 60, 75, 90, 105, 120 minutes, 2.5, 3, 4, 6, 8, and 12 hours post-dose
Elimination Half-life (t1/2) of Ibuprofen in Fasted Conditions
t1/2 was defined as elimination half-life calculated as t1/2 = ln (2)/λz where λz was terminal elimination rate constant. Blood samples were collected at indicated timepoints for the analysis of t1/2. PK parameters were determined by non-compartmental analysis.
Measured: Pre-dose (within 2 hours prior to dosing) and at 5, 10, 15, 20, 30, 45, 60, 75, 90, 105, 120 minutes, 2.5, 3, 4, 6, 8, and 12 hours post-dose
Terminal Elimination Rate Constant (λz) of Ibuprofen in Fasted Conditions
λz was defined as terminal elimination rate constant estimated by log-linear regression of the terminal part of the plasma concentration versus time curve. Blood samples were collected at indicated timepoints for the analysis of λz. PK parameters were determined by non-compartmental analysis.
Measured: Pre-dose (within 2 hours prior to dosing) and at 5, 10, 15, 20, 30, 45, 60, 75, 90, 105, 120 minutes, 2.5, 3, 4, 6, 8, and 12 hours post-dose
Percentage of Extrapolated Area of AUC(0-inf) (%AUCex) of Ibuprofen in Fasted Conditions
%AUCex was calculated as %AUCex = (1- AUC[0-t] /AUC[0-inf])*100%. Blood samples were collected at indicated timepoints for the analysis of %AUCex. PK parameters were determined by non-compartmental analysis.
Measured: Pre-dose (within 2 hours prior to dosing) and at 5, 10, 15, 20, 30, 45, 60, 75, 90, 105, 120 minutes, 2.5, 3, 4, 6, 8, and 12 hours post-dose
Tmax of Ibuprofen in Fed Conditions
Blood samples were collected at indicated timepoints for the analysis of Tmax. PK parameters were determined by non-compartmental analysis.
Measured: Pre-dose (within 2 hours prior to dosing) and 10, 30, 45, 60, 75, 90, 120 minutes, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10 and 12 hours post-dose
t1/2 of Ibuprofen in Fed Conditions
t1/2 was defined as elimination half-life calculated as t1/2 = ln (2)/λz where λz was terminal elimination rate constant. Blood samples were collected at indicated timepoints for the analysis of t1/2. PK parameters were determined by non-compartmental analysis.
Measured: Pre-dose (within 2 hours prior to dosing) and 10, 30, 45, 60, 75, 90, 120 minutes, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10 and 12 hours post-dose
λz of Ibuprofen in Fed Conditions
λz was defined as terminal elimination rate constant estimated by log-linear regression of the terminal part of the plasma concentration versus time curve. Blood samples were collected at indicated timepoints for the analysis of λz. PK parameters were determined by non-compartmental analysis.
Measured: Pre-dose (within 2 hours prior to dosing) and 10, 30, 45, 60, 75, 90, 120 minutes, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10 and 12 hours post-dose
%AUCex of Ibuprofen in Fed Conditions
%AUCex was calculated as %AUCex = (1- AUC[0-t] /AUC[0-inf])*100%. Blood samples were collected at indicated timepoints for the analysis of %AUCex. PK parameters were determined by non-compartmental analysis.
Measured: Pre-dose (within 2 hours prior to dosing) and 10, 30, 45, 60, 75, 90, 120 minutes, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10 and 12 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start19 Apr 2023
- Primary completion15 May 2023
- Study completion15 May 2023
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 PainStudies 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
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- HALEON
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Min Xu, Master, Principal investigator, Clinical Pharmacological Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05737069
- Sponsor's protocol ID
- 218552
- Status last verified
- May 2024
- First submitted
- 10 Feb 2023
- Last updated
- 19 Sep 2024
- 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-trial-register@haleon.com
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Single-center, Single-dose, Two Treatment, Two-sequence, Two-period, Two-cohort, Two-way Crossover Bioequivalence Study of Two Ibuprofen Arginine Granules 400 mg Formulations Under Fasting and Fed Conditions in Chinese Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT05737069
- Acronym / sponsor ID
- 218552
- Conditions
- Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- HALEONIndustry (pharma, biotech, devices)
- Study start
- 19 Apr 2023 (actual)
- Primary completion
- 15 May 2023 (actual)
- Study completion
- 15 May 2023 (actual)
- First posted
- 21 Feb 2023 (actual)
- Results
- Posted 19 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this study is to demonstrate the bioequivalence of two ibuprofen arginine granules 400 milligram (mg) formulations under fasting and fed conditions in Chinese healthy adult participants. The secondary purpose of this study is to assess the pharmacokinetic and safety profile of the test and reference preparations.
Detailed description
The bioequivalence study adopts a single-center, randomized, open-label, single-dose, two-treatment, two-sequence, two-period, two-cohort, two-way crossover design with at least 2-day washout period, under both fasting and fed conditions in Chinese healthy adult participants. It will be planned to enroll approximately 84 participants out of which the first 34 participants for the fasted cohort and the subsequent 50 participants for the fed cohort receiving ibuprofen arginine granules 400 mg. Participants will be randomly assigned to either one of the 2 treatment (Test or Reference product) sequences in a 1:1 ratio within fasted cohort and fed cohort.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ibuprofen arginine granules 400 mg | Experimental | Drug: Ibuprofen arginine granules 400 mg, Drug: Ibuprofen arginine granules 400 mg (Spedifen)Participants will be randomly assigned as per cross-over design to receive one sachet of Ibuprofen arginine granules 400 mg (test product) on day 1 of period 1 and will receive one sachet of Ibuprofen arginine granules 400 mg (Spedifen) (reference product) on day 1 of period 2 with at least 2 days washout period. Participants will be instructed to consume the product orally by dissolving it in 240 mL of warm water. |
| Ibuprofen arginine granules 400 mg (Spedifen) | Active comparator | Drug: Ibuprofen arginine granules 400 mg, Drug: Ibuprofen arginine granules 400 mg (Spedifen)Participants will be randomly assigned as per cross-over design to receive one sachet of Ibuprofen arginine granules 400 mg (Spedifen) (reference product) on day 1 of period 1 and will receive one sachet of Ibuprofen arginine granules 400 mg (test product) on day 1 of period 2 with at least 2 days washout period. Participants will be instructed to consume the product orally by dissolving it in 240 mL of warm water. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Participants provision of a signed and dated informed consent and/or assent document indicating that the participant has been informed of all pertinent aspects of the study before any assessment is performed.
- Participants who is willing and able to comply with scheduled visits, treatment plan, laboratory tests, study restrictions, lifestyle considerations and other study procedures.
- Healthy Participants, which is defined as in general good physical health, as judged by the investigator and no clinically significant relevant abnormalities identified by a detailed medical history, full physical examination, including vital signs, 12-lead electrocardiogram (ECG) and laboratory tests.
- A Participants with a Body Mass Index (BMI) of 19-26 kilogram per meter square (kg/m^2) (including 19, excluding 26) [BMI equal to (=) weight (Kilogram [kg])/height^2 (m^2)]; and a total body weight more than or equal to >= 50 kilogram (kg) for males, and >= 45 kg for females, at screening.
- Participants with one negative polymerase chain reaction (PCR) or antigen test (on Day-1) for active Coronavirus disease 2019 (COVID-19).
Key exclusion criteria (34 listed)
- Known or suspected intolerance or hypersensitivity or photosensitivity to the investigational products (or closely related compounds) or any of their stated ingredients.
- Allergy to skin disinfecting agents, tape, or latex rubber, whenever appropriate substitutions cannot be applied or in the investigator's opinion may pose a risk to the candidate.
- Diagnosis of long QT syndrome or QTcF > 450 millisecond (msec) at screening.
- Clinically significant vital sign abnormalities (systolic blood pressure lower than 90 or over 140 millimeters of mercury (mmHg), diastolic blood pressure lower than 60 or over 90 mmHg, or pulse rate less than 50 or over 100 beats per minute [bpm]).
- Use of any medication (including over-the-counter medications and Chinese herbal and traditional remedies) within 2 weeks before first scheduled study drug administration or within less than 10 times the elimination half-life of the concomitant medication (whichever is longer) or is anticipated to require any concomitant medication during that period or at any time throughout the study. Allowed treatments are:
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 |
|---|---|---|
| Ibuprofen arginine granules 400 mgExperimental- Ibuprofen arginine granules 400 mg, one sachet administration containing 400 mg ibuprofen granules. | Drug | Ibuprofen arginine granules 400 mg, Ibuprofen arginine granules 400 mg (Spedifen) |
| Ibuprofen arginine granules 400 mg (Spedifen)Marketed drug- Ibuprofen arginine granules 400 mg (Spedifen), one sachet administration containing 400 mg ibuprofen granules. | Drug | Ibuprofen arginine granules 400 mg, Ibuprofen arginine granules 400 mg (Spedifen) |
Primary outcome
Area Under the Plasma Concentration Time Curve From Time Zero to Last Observed Concentration at Time t (AUC[0-t]) for Ibuprofen in Fasted Conditions
Time frame: Pre-dose (within 2 hours prior to dosing) and at 5, 10, 15, 20, 30, 45, 60, 75, 90, 105, 120 minutes, 2.5, 3, 4, 6, 8, and 12 hours post-dose
AUC(0-t) was defined as area under the plasma concentration-time curve from time zero to last observed concentration at time t calculated using the linear up log down trapezoidal rule. Blood samples were collected at indicated timepoints for the analysis of AUC(0-t). Pharmacokinetic (PK) parameters were determined by non-compartmental analysis.
Area Under the Plasma Concentration Time Curve From Time Zero to Time Infinity (AUC [0-inf]) for Ibuprofen in Fasted Conditions
Time frame: Pre-dose (within 2 hours prior to dosing) and at 5, 10, 15, 20, 30, 45, 60, 75, 90, 105, 120 minutes, 2.5, 3, 4, 6, 8, and 12 hours post-dose
AUC (0-inf) was defined as area under the plasma concentration versus time curve calculated from time 0 to infinity, computed as AUC(0-inf) = AUC(0-t) +Ct/λz where Ct was the plasma concentration at the last measurable sampling time point and λz was the terminal elimination rate constant. Blood samples were collected at indicated timepoints for the analysis of AUC(0-inf). PK parameters were determined by non-compartmental analysis.
Observed Maximum Plasma Concentration (Cmax) for Ibuprofen in Fasted Conditions
Time frame: Pre-dose (within 2 hours prior to dosing) and at 5, 10, 15, 20, 30, 45, 60, 75, 90, 105, 120 minutes, 2.5, 3, 4, 6, 8, and 12 hours post-dose
Cmax was defined as maximum observed post-dose plasma concentration for ibuprofen. Blood samples were collected at indicated timepoints for the analysis of Cmax. PK parameters were determined by non-compartmental analysis.
AUC(0-t) for Ibuprofen in Fed Conditions
Time frame: Pre-dose (within 2 hours prior to dosing) and 10, 30, 45, 60, 75, 90, 120 minutes, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10 and 12 hours post-dose
AUC(0-t) was defined as area under the plasma concentration-time curve from time zero to last observed concentration at time t calculated using the linear up log down trapezoidal rule. Blood samples were collected at indicated timepoints for the analysis of AUC(0-t). PK parameters were determined by non-compartmental analysis.
AUC (0-inf) for Ibuprofen in Fed Conditions
Time frame: Pre-dose (within 2 hours prior to dosing) and 10, 30, 45, 60, 75, 90, 120 minutes, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10 and 12 hours post-dose
AUC (0-inf) was defined as area under the plasma concentration versus time curve calculated from time 0 to infinity, computed as AUC(0-inf) = AUC(0-t) +Ct/λz where Ct was the plasma concentration at the last measurable sampling time point and λz was the terminal elimination rate constant. Blood samples were collected at indicated timepoints for the analysis of AUC(0-inf). PK parameters were determined by non-compartmental analysis.
Cmax for Ibuprofen in Fed Conditions
Time frame: Pre-dose (within 2 hours prior to dosing) and 10, 30, 45, 60, 75, 90, 120 minutes, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10 and 12 hours post-dose
Cmax was defined as maximum observed post-dose plasma concentration for ibuprofen. Blood samples were collected at indicated timepoints for the analysis of Cmax. PK parameters were determined by non-compartmental analysis.
8 secondary outcomes
Time to Reach Maximum Plasma Concentration (Tmax) of Ibuprofen in Fasted Conditions
Time frame: Pre-dose (within 2 hours prior to dosing) and at 5, 10, 15, 20, 30, 45, 60, 75, 90, 105, 120 minutes, 2.5, 3, 4, 6, 8, and 12 hours post-dose
Elimination Half-life (t1/2) of Ibuprofen in Fasted Conditions
Time frame: Pre-dose (within 2 hours prior to dosing) and at 5, 10, 15, 20, 30, 45, 60, 75, 90, 105, 120 minutes, 2.5, 3, 4, 6, 8, and 12 hours post-dose
Terminal Elimination Rate Constant (λz) of Ibuprofen in Fasted Conditions
Time frame: Pre-dose (within 2 hours prior to dosing) and at 5, 10, 15, 20, 30, 45, 60, 75, 90, 105, 120 minutes, 2.5, 3, 4, 6, 8, and 12 hours post-dose
Percentage of Extrapolated Area of AUC(0-inf) (%AUCex) of Ibuprofen in Fasted Conditions
Time frame: Pre-dose (within 2 hours prior to dosing) and at 5, 10, 15, 20, 30, 45, 60, 75, 90, 105, 120 minutes, 2.5, 3, 4, 6, 8, and 12 hours post-dose
Tmax of Ibuprofen in Fed Conditions
Time frame: Pre-dose (within 2 hours prior to dosing) and 10, 30, 45, 60, 75, 90, 120 minutes, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10 and 12 hours post-dose
t1/2 of Ibuprofen in Fed Conditions
Time frame: Pre-dose (within 2 hours prior to dosing) and 10, 30, 45, 60, 75, 90, 120 minutes, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10 and 12 hours post-dose
λz of Ibuprofen in Fed Conditions
Time frame: Pre-dose (within 2 hours prior to dosing) and 10, 30, 45, 60, 75, 90, 120 minutes, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10 and 12 hours post-dose
%AUCex of Ibuprofen in Fed Conditions
Time frame: Pre-dose (within 2 hours prior to dosing) and 10, 30, 45, 60, 75, 90, 120 minutes, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10 and 12 hours post-dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- 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-trial-register@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.
Min Xu, Master principal investigator
Clinical Pharmacological Research Center
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 Ibuprofen arginine granules 400 mg and Ibuprofen arginine granules 400 mg (Spedifen) in people with Pain, run by HALEON at 1 site in China.
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 6 inclusion and 34 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 19 Sep 2024. 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 China. 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 19 Sep 2024). 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?
Area Under the Plasma Concentration Time Curve From Time Zero to Last Observed Concentration at Time t (AUC[0-t]) for Ibuprofen in Fasted Conditions (time frame: Pre-dose (within 2 hours prior to dosing) and at 5, 10, 15, 20, 30, 45, 60, 75, 90, 105, 120 minutes, 2.5, 3, 4, 6, 8, and 12 hours post-dose). 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?
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 19 Sep 2024.