Clinical trial NCT01316978: A Study to Test Bioequivalence Between One Test Formulation of Ibuprofen and Two Reference Treatments
Official title: A Single-Dose, Randomised, Crossover Bioequivalence Study to Compare the Rate and Extent of Absorption of a Test Formulation of Ibuprofen Fast Melt Orodispersible Tablet Versus Two Reference Formulations in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pain
Lead sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Sponsor class: INDUSTRY
First posted: 2011-03-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study is designed to assess bioequivalence between one test and two reference formulations used for treatment of headaches and temporary relief of pain.

Detailed description: The study is a single dose, randomized, three-way crossover study in 30 healthy subjects, with equal numbers of males and females (minimum of 13 of either gender). Drop-outs will not be replaced. The three doses of medication given in the study (a single dose in each of the three study periods) will each be separated by a washout period of at least 7 calendar days. In each study period, eighteen (18) blood samples for pharmacokinetic analysis will be taken over 12 hours. Blood samples will be centrifuged and concentrations of ibuprofen (R-enantiomer and S-enantiomer) in plasma will be measured using a validated chromatographic assay. Pharmacokinetic parameters will be calculated from plasma concentration data \[R-enantiomer, S-enantiomer and total (sum of both enantiomers)\]. The rate and extent of absorption of the formulations will be compared.

Eligibility criteria: Inclusion Criteria:

* Male or female subjects (equal numbers of males and females)
* Volunteers aged of at least 18 years but not older than 55 years
* Subjects will have a Body Mass Index (BMI) greater than or equal to 18.5 and below 30 kg/m2; and a total body weight \>50 kg
* Non- or ex-smokers; an ex-smoker being defined as someone who completely stopped smoking for at least 12 months before day 1 of this study.
* Clinical laboratory values within the laboratory's stated normal range; if not within this range, they must be without any clinical significance
* Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on physical examination and/or clinical laboratory evaluations (hematology, biochemistry, ECG and urinalysis)
* Has signed and dated the informed consent document, indicating that the subject has been informed of all pertinent aspects of the study
* Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures

Exclusion Criteria:

* Seated pulse rate below 45 bpm or higher than 90 bpm at screening
* Seated blood pressure below 90/60 mmHg or higher than 140/90 mmHg at screening
* Relationship to persons involved directly with the conduct of the study (i.e., principal investigator; sub-investigators; study coordinators; other study personnel; employees or contractors of the sponsor or Johnson \& Johnson subsidiaries; and the families of each)
* Presence of any tongue piercings
* Presence of braces
* Females who are pregnant or are lactating
* Females of childbearing potential or males with a female partner of childbearing potential who refuse to use an acceptable contraceptive regimen throughout the entire duration of the study
* Females who are pregnant according to a positive serum pregnancy test
* Any medical history or condition, or use of any drug or medication, that the investigator determines could compromise subject safety or the evaluation of results.

Primary outcomes:
measure: Maximum Observed Plasma Concentration
timeFrame: During 12 hours post-dose
measure: Bioavailability [AUC(0-t)]
timeFrame: During 12 hours post-dose
Secondary outcomes:
measure: Bioavailability Extrapolated to Infinity [AUC (0-∞)]
timeFrame: 12 hours post-dose
measure: Time of Maximum Concentration
timeFrame: During 12 hours post-dose
measure: Terminal Elimination Rate Constant
timeFrame: During 12 hours post-dose
measure: Terminal Phase Plasma Half-Life
timeFrame: During 12 hours post-dose
Other outcomes:
Locations:
city: Mount-Royal
country: Canada
facility: Algorithme Pharma Inc.
state: Quebec
Study officials:
affiliation: McNeil AB
name: Elisabeth Kruse, PhD
role: STUDY_DIRECTOR
References: