Bioequivalence Study Between Two Oral Formulations of Ibuprofen 800 mg Tablets Under Fasting Conditions
- Registration Number
- NCT00804440
- Lead Sponsor
- Perrigo Company
- Brief Summary
Compare the rate and extent of absorption of two oral formulations of Ibuprofen 800 mg Tablets, administered as a single, one-tablet dose in fasted subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
- healthy men or women, 18 years of age or older
- body mass index between 19 and 30
- willing to participate and sign a copy of the informed consent form
Exclusion Criteria
- history of allergy or hypersensitivity to ibuprofen
- recent history of drug or alcohol addiction or abuse
- pregnant or lactating women
- use of tobacco products within 3 months prior to study dosing
- evidence of a clinically significant disorder or whose laboratory results were deemed to be clinically significant
- receipt of any drugs as part of a research study within 30 days prior to study dosing
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Test Product Ibuprofen Tablets, 800 mg - Reference Product Ibuprofen Tablets, 800 mg -
- Primary Outcome Measures
Name Time Method Bioequivalence was assessed on the pharmacokinetic variables Cmax, AUC,0-t, and AUC,0-infinity
- Secondary Outcome Measures
Name Time Method