Bioequivalence Study Between Two Oral Formulations of Gemfibrozil Tablets
- Registration Number
- NCT00800475
- Lead Sponsor
- Blu Caribe
- Brief Summary
The purpose of this study is to determine whether two oral formulations of Gemfibrozil Tablets are bioequivalent.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
- healthy men or women 18 years of age or older
- weight within +/- 20% for height and body frame
- willing to participate and sign a copy of the informed consent form
Exclusion Criteria
- recent history of drug or alcohol addiction or abuse
- pregnant or lactating women
- history of allergic response to gemfibrozil
- use of tobacco products
- 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 28 days prior to study dosing
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Test Drug Gemfibrozil Tablets - Reference Drug Gemfibrozil Tablets -
- Primary Outcome Measures
Name Time Method Bioequivalence was assessed on the pharmacokinetic variables, Cmax, AUCO-t and AUCO-infinity
- Secondary Outcome Measures
Name Time Method