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.