Overview

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

Status:
Completed
Trial end date:
2011-03-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
McNeil AB
Treatments:
Ibuprofen
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.