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A Study to Test Bioequivalence Between One Test Formulation of Ibuprofen and Two Reference Treatments

Information source: Johnson & Johnson Consumer and Personal Products Worldwide
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pain

Intervention: Ibuprofen (Drug); Ibuprofen (Drug); Ibuprofen (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: McNeil AB

Official(s) and/or principal investigator(s):
Elisabeth Kruse, PhD, Study Director, Affiliation: McNeil AB

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Basic Science

Primary outcome:

Maximum Observed Plasma Concentration

Bioavailability [AUC(0-t)]

Secondary outcome:

Bioavailability Extrapolated to Infinity [AUC (0-∞)]

Time of Maximum Concentration

Terminal Elimination Rate Constant

Terminal Phase Plasma Half-Life

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

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

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.

Locations and Contacts

Algorithme Pharma Inc., Mount-Royal, Quebec H3P 3P1, Canada
Additional Information

Starting date: February 2011
Last updated: July 6, 2012

Page last updated: August 23, 2015

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