Bioequivalence Study Between Two Oral Formulations of Naproxen 500 mg Tablets Under Fasting Conditions
- Registration Number
- NCT00804401
- Lead Sponsor
- Perrigo Company
- Brief Summary
Compare the rate and extent of absorption of two oral formulations of Naproxen Tablets, administered as a 1 x 500 mg tablet under fasting conditions.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 34
Inclusion Criteria
- healthy men or women, non-smoker, 18 years of age or older
- willing to participate and sign a copy of the informed consent form
Exclusion Criteria
- clinically significant illnesses or surgery within 4 weeks prior to study dosing
- body mass index greater than or equal to 30.0
- recent history of drug or alcohol addiction or abuse
- pregnant or lactating women
- history of allergic response to naproxen, NSAIDs, or other related drugs, or to heparin
- history of allergic reactions such as asthma, rhinitis, nasal polyps, urticaria, and hypotension associated with the use of aspirin or other NSAIDs
- history or known presence of gastrointestinal ulceration, bleeding and perforation
- use of tobacco products within 6 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 Naproxen Tablets, 500 mg - Reference Product Naproxen Tablets, 500 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