A Study to Test Bioequivalence Between One Test Formulation of Ibuprofen and Two Reference Treatments
Status and phase
Conditions
Treatments
Details and patient eligibility
About
This study is designed to assess bioequivalence between one test and two reference formulations used for treatment of headaches and temporary relief of pain.
Full 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.
Enrollment
Sex
Ages
Volunteers
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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
30 participants in 3 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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