Fenofibrate Bioequivalence Study (0767-031)
Phase 1
Completed
- Conditions
- Dyslipidemia
- Interventions
- Registration Number
- NCT00928694
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
This study will determine definitive bioequivalence of the United States (U.S.) and United Kingdom (UK) formulations of fenofibrate following administration of single doses in healthy adult subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 14
Inclusion Criteria
- Subject is in good health
- Subject is willing to follow all study guidelines
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Exclusion Criteria
- Subject has uncontrolled high blood pressure, impaired glucose tolerance, diabetes, or other major diseases or chronic conditions that would confound the results of the study or make participation unsafe
- Female subject is receiving oral contraceptives or hormone replacement therapy
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 1 fenofibrate (U.S. formulation) Fenofibrate U.S. Formulation 2 fenofibrate (UK formulation) Fenofibrate UK Formulation
- Primary Outcome Measures
Name Time Method Area Under the Curve (AUC(0 to Infinity)) of Fenofibric Acid Predose and up to 168 hours postdose Maximum Plasma Concentration (Cmax) of Fenofibric Acid Predose and up to 168 hours postdose
- Secondary Outcome Measures
Name Time Method