Fenofibrate Bioequivalence Study (0767-031)

Merck Sharp & Dohme LLC14 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Dyslipidemia

Interventions

fenofibrate (U.S. formulation)DRUG

Single dose of 160 mg fenofibrate U.S. formulation (Tricor®) in one of two treatment periods.

fenofibrate (UK formulation)DRUG

Single dose of 160 mg fenofibrate UK formulation (Supralip®) in one of two treatment periods.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Area Under the Curve (AUC(0 to Infinity)) of Fenofibric Acid

Time frame: Predose and up to 168 hours postdose

Maximum Plasma Concentration (Cmax) of Fenofibric Acid

Time frame: Predose and up to 168 hours postdose

Data from ClinicalTrials.gov

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