Infections, Respiratory TractPhase 1NCT02688361
A Bioequivalence Study of an Acetylcysteine 2% Oral Solution Versus a Reference Fluimucil 2% Oral Solution
A Phase 1 study testing Fluimucil® 2% solution and Acetylcysteine 2% solution in people with Infections, Respiratory Tract, run by GlaxoSmithKline at 1 site in Germany.
Trial summary
This is an open-label, randomized, single-center, 2-period, 2-sequence, single-dose crossover design study in adult male and female healthy participants. Eligible participants will receive either treatment A (reference): Fluimucil® Acetylcysteine 2% oral solution, 200 mg N- acetylcysteine (NAC) in 10 mL dose, or… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Infections, Respiratory Tract
- What is being tested?
- Fluimucil® 2% solution and Acetylcysteine 2% solution
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteGermany
- Study dates
- 22 Feb 2016to 13 Apr 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants must understand and provide written informed consent before any assessment is performed, understand the study procedures, and be willing to complete the required assessments.
- Male and female participants of any ethnic origin between 18 and 45 years of age. Body Mass Index (BMI) of 18.5 to 30 kg/m2, inclusive. Minimal body weight of 50 kg, inclusive.
- Normal vital signs as follows: Oral body temperature between 35.0 and 37.5 ºC inclusive; Sitting systolic blood pressure between 90 and 140 mmHg inclusive; Sitting diastolic blood pressure between 55 and 90 mmHg inclusive; Sitting pulse rate between 50 and 100 bpm inclusive.
- In general, good physical health, as judged by the Investigator and determined by medical/surgical history, physical examination, electrocardiogram (ECG, 12-lead) and clinical laboratory (clinical chemistry and hematology) findings.
Who cannot join
- Use of other investigational drugs within 3 months or 10 half-lives of enrollment, whichever is longer.
- History of or known hypersensitivity to any of the study drugs, excipients or to drugs of similar chemical or pharmacological classes.
- Diagnosis of long QT syndrome or QTc (Fridericia preferred, but Bazett acceptable) ≥ 450 msec for males and ≥ 470 msec for females at screening.
- History of malignancy or neoplastic disease of any organ system (except for localized basal cell skin carcinoma), treated or untreated, within the past 5 years prior to screening, regardless of whether there is evidence of local recurrence or metastases.
- Pregnant, Women of child-bearing potential or breastfeeding women.
- Any surgical or medical condition which may significantly alter the absorption, distribution, metabolism or excretion of any drug substance
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- History (within 5 years prior to study start) of clinically significant gastritis, pyloric channel stenosis, peptic ulcer or duodenal ulceration, gastro-esophageal reflux, gastrointestinal bleeding, rectal bleeding or other clinically significant GI abnormalities.
- History (within 5 years prior to study start) of orthostatic hypotension, cardiovascular disease, stroke, transient ischemic attack, fainting or blackouts.
- Clinically relevant chronic or acute infectious illnesses or febrile infections within 2 weeks prior to start of the study.
- Newly occurred (within 2 weeks of screening visit) cutaneous and mucosal alterations.
- Participants with histamine intolerance.
- Positive results in any of the virology tests for Human Immunodeficiency Virus-Ab, Hepatitis C Antibody (HCV-Ab), Surface Antigen of the Hepatitis B Virus (HBsAg), and Hepatitis B Core Antibody (HBc-Ab).
- Any evidence of clinically significant cardiovascular, pulmonary, renal, hepatic, gastrointestinal, hematological, endocrinological, metabolic, autoimmune, neurological, psychiatric or other diseases at screening.
- Participant has used any medication (including over-the-counter medications) within 2 weeks before first scheduled study drug administration or within < 10 times the elimination halflife of the respective drug (whichever is longer), or is anticipated to require any concomitant medication during that period or at any time throughout the study.
- Participant reports consumption of any drug metabolizing enzyme (e.g. CYP3A4 or other cytochrome P450 enzymes) inducing or inhibiting aliments, beverages or food supplements within two weeks prior to the first scheduled study drug administration, or is anticipated to consume such products during that two-week period or at any time throughout the study.
- Any history of drug hypersensitivity, asthma, urticaria, or other significant allergic diathesis, illicit drug abuse.
- Participant shows evidence for current alcohol abuse or smoking.
- "Vulnerable" individuals.
- Participation in a previous clinical study with or without another investigational product and with ~470 ml blood drawn, or blood donation within the last 3 months prior to screening or previous enrollment into the current study.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-Label, Two-Period, Crossover Bioequivalence Study in Healthy Adult Subjects After Single Oral Dosing of a NCH-GSK Acetylcysteine 2% Oral Solution Versus a Reference Fluimucil® Acetylcysteine 2% Oral Solution
This is an open-label, randomized, single-center, 2-period, 2-sequence, single-dose crossover design study in adult male and female healthy participants. Eligible participants will receive either treatment A (reference): Fluimucil® Acetylcysteine 2% oral solution, 200 mg N- acetylcysteine (NAC) in 10 mL dose, or treatment B (test): Acetylcysteine 2% oral solution, 200 mg NAC in 10 mL dose. Blood sampling will be collected pre-dose and up to 48 hours in each period. After completion of the second study period (i.e. last pharmacokinetic (PK) sample on Day 3 of Period 2) participants will be discharged from the clinic.
- Conditions
- Infections, Respiratory Tract
- Being tested
- Fluimucil® 2% solution, Acetylcysteine 2% solution
- Medical subject headings
- Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluimucil® 2% solutionDrug
Participants will be orally administered with 10ml of 2% oral solution of Fluimucil® (reference).
Acetylcysteine 2% solutionDrug
Participants will be orally administered with 10ml of 2% oral solution of Acetylcysteine (test)
| Study group | Role | What they receive |
|---|---|---|
| Fluimucil® (reference) then Acetylcysteine (test) 2% solution | Experimental | Participants will be orally administered with 10ml of 2% oral solution of Fluimucil® (reference) following a wash out period of at least a week then administration of by 10ml of 2% oral solution of Acetylcysteine (test). Receives: Drug: Fluimucil® 2% solution |
| Acetylcysteine (test) 2% solution then Fluimucil® (reference) | Experimental | Participants will be orally administered with 10ml of 2% oral solution of Acetylcysteine (test) following a wash out period of at least a week then administration of by 10ml of 2% oral solution of Fluimucil® (reference). Receives: Drug: Acetylcysteine 2% solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve from time zero to last sampling time [AUC(0-last)]
AUC(0-last) of acetylcysteine will be calculated using trapezoidal rule. Blood samples will be taken pre-dose and upto 48 hours post-dose of administration of the reference/test product in each period.
Measured: 3 days
Maximum Plasma Concentration (Cmax)
Cmax of acetylcysteine will be obtained graphically from the plasma concentration over time profile. Blood samples will be taken pre-dose and upto 48 hours post-dose of administration of the reference/test product in each period.
Measured: 3 days
Secondary outcomes (5)
Area under the curve from time zero to infinity [AUC(0-inf.)]
AUC(0-inf.) of acetylcysteine will be calculated using trapezoidal rule. Blood samples will be taken pre-dose and upto 48 hours post-dose of administration of the reference/test product in each period.
Measured: 3 days
Time to reach maximum plasma concentration (Tmax)
Tmax of acetylcysteine will be obtained graphically from the plasma concentration over time profile. Blood samples will be taken pre-dose and upto 48 hours post-dose of administration of the reference/test product in each period.
Measured: 3 days
Termination rate constant (Lambda_z)
Lambda_z will be computed as the slope of the regression line of ln (C(t)) on time.
Measured: 3 days
Residual Area (RA)
RA will be calculated as percent extrapolated area (= (AUCinf - AUClast)/ AUCinf)*100%).
Measured: 3 days
Elimination half life (t1/2)
T1/2 will be computed as T1/2 = 0.693/ λz
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2016 (estimated)
- Study start22 Feb 2016
- Primary completion13 Apr 2016
- Study completion13 Apr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infections, Respiratory TractStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKlineGSK Clinical Trials, Study director, GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02688361
- Sponsor's protocol ID
- 205033
- Status last verified
- Dec 2018
- First submitted
- 18 Feb 2016
- Last updated
- 24 Jan 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Two-Period, Crossover Bioequivalence Study in Healthy Adult Subjects After Single Oral Dosing of a NCH-GSK Acetylcysteine 2% Oral Solution Versus a Reference Fluimucil® Acetylcysteine 2% Oral Solution
- ClinicalTrials.gov ID
- NCT02688361
- Acronym / sponsor ID
- 205033
- Conditions
- Infections, Respiratory Tract
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 22 Feb 2016 (actual)
- Primary completion
- 13 Apr 2016 (actual)
- Study completion
- 13 Apr 2016 (actual)
- First posted
- 23 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label, randomized, single-center, 2-period, 2-sequence, single-dose crossover design study in adult male and female healthy participants. Eligible participants will receive either treatment A (reference): Fluimucil® Acetylcysteine 2% oral solution, 200 mg N- acetylcysteine (NAC) in 10 mL dose, or treatment B (test): Acetylcysteine 2% oral solution, 200 mg NAC in 10 mL dose. Blood sampling will be collected pre-dose and up to 48 hours in each period. After completion of the second study period (i.e. last pharmacokinetic (PK) sample on Day 3 of Period 2) participants will be discharged from the clinic.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fluimucil® (reference) then Acetylcysteine (test) 2% solution | Experimental | Drug: Fluimucil® 2% solutionParticipants will be orally administered with 10ml of 2% oral solution of Fluimucil® (reference) following a wash out period of at least a week then administration of by 10ml of 2% oral solution of Acetylcysteine (test). |
| Acetylcysteine (test) 2% solution then Fluimucil® (reference) | Experimental | Drug: Acetylcysteine 2% solutionParticipants will be orally administered with 10ml of 2% oral solution of Acetylcysteine (test) following a wash out period of at least a week then administration of by 10ml of 2% oral solution of Fluimucil® (reference). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Participants must understand and provide written informed consent before any assessment is performed, understand the study procedures, and be willing to complete the required assessments.
- Male and female participants of any ethnic origin between 18 and 45 years of age. Body Mass Index (BMI) of 18.5 to 30 kg/m2, inclusive. Minimal body weight of 50 kg, inclusive.
- Normal vital signs as follows: Oral body temperature between 35.0 and 37.5 ºC inclusive; Sitting systolic blood pressure between 90 and 140 mmHg inclusive; Sitting diastolic blood pressure between 55 and 90 mmHg inclusive; Sitting pulse rate between 50 and 100 bpm inclusive.
- In general, good physical health, as judged by the Investigator and determined by medical/surgical history, physical examination, electrocardiogram (ECG, 12-lead) and clinical laboratory (clinical chemistry and hematology) findings.
Key exclusion criteria (20 listed)
- Use of other investigational drugs within 3 months or 10 half-lives of enrollment, whichever is longer.
- History of or known hypersensitivity to any of the study drugs, excipients or to drugs of similar chemical or pharmacological classes.
- Diagnosis of long QT syndrome or QTc (Fridericia preferred, but Bazett acceptable) ≥ 450 msec for males and ≥ 470 msec for females at screening.
- History of malignancy or neoplastic disease of any organ system (except for localized basal cell skin carcinoma), treated or untreated, within the past 5 years prior to screening, regardless of whether there is evidence of local recurrence or metastases.
- Pregnant, Women of child-bearing potential or breastfeeding women.
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 |
|---|---|---|
| Fluimucil® 2% solutionParticipants will be orally administered with 10ml of 2% oral solution of Fluimucil® (reference). | Drug | Fluimucil® (reference) then Acetylcysteine (test) 2% solution |
| Acetylcysteine 2% solutionParticipants will be orally administered with 10ml of 2% oral solution of Acetylcysteine (test) | Drug | Acetylcysteine (test) 2% solution then Fluimucil® (reference) |
Primary outcome
Area under the curve from time zero to last sampling time [AUC(0-last)]
Time frame: 3 days
AUC(0-last) of acetylcysteine will be calculated using trapezoidal rule. Blood samples will be taken pre-dose and upto 48 hours post-dose of administration of the reference/test product in each period.
Maximum Plasma Concentration (Cmax)
Time frame: 3 days
Cmax of acetylcysteine will be obtained graphically from the plasma concentration over time profile. Blood samples will be taken pre-dose and upto 48 hours post-dose of administration of the reference/test product in each period.
5 secondary outcomes
Area under the curve from time zero to infinity [AUC(0-inf.)]
Time frame: 3 days
Time to reach maximum plasma concentration (Tmax)
Time frame: 3 days
Termination rate constant (Lambda_z)
Time frame: 3 days
Residual Area (RA)
Time frame: 3 days
Elimination half life (t1/2)
Time frame: 3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2019.
- Results for Study 205033 can be found on the GSK Clinical Study RegisterLink provided by the sponsor.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
GSK Clinical Trials study director
GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)
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 Fluimucil® 2% solution and Acetylcysteine 2% solution in people with Infections, Respiratory Tract, run by GlaxoSmithKline 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 4 inclusion and 20 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 24 Jan 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 curve from time zero to last sampling time [AUC(0-last)] (time frame: 3 days). The study lists 2 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 24 Jan 2019.