Phase 1
Completed N=14
Fenofibrate Bioequivalence Study (0767-031)
Source: ClinicalTrials.gov NCT00928694 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Dec 2009
Primary outcomePrimary: Area Under the Curve (AUC(0 to Infinity)) of Fenofibric Acid — 116; 121 μg·hr/mL
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.
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 | — |
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. Informational only — not medical advice.