Phase 1
N=14
Fenofibrate Bioequivalence Study (0767-031)
Dyslipidemia
Bottom Line
View on ClinicalTrials.gov: NCT00928694 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Dec 2009
Primary outcome: Primary: Area Under the Curve (AUC(0 to Infinity)) of Fenofibric Acid — 116; 121 μg·hr/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- fenofibrate (U.S. formulation) (Drug); fenofibrate (UK formulation) (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Apr 2003
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Curve (AUC(0 to Infinity)) of Fenofibric Acid |
116; 121 | — |
| PRIMARY Maximum Plasma Concentration (Cmax) of Fenofibric Acid |
6.35; 6.48 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Subject is in good health
- Subject is willing to follow all study guidelines
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
Data sourced from ClinicalTrials.gov (NCT00928694). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.