Fenofibrate Bioequivalence Study (0767-031)

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.

Completed

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Key information

Conditions

Dyslipidemia Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

fenofibrate (U.S. formulation)

Drug

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

Other names: Tricor®

fenofibrate (UK formulation)

Drug

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

Other names: Supralip®

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

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

An Open-Label, Randomized, 2-Period, Crossover Study to Determine Definitive Bioequivalence After Administration of Single 160 mg Doses of the U.S. and UK Formulations of Fenofibrate in Healthy Adult Subjects

Important dates

Study start: 2003
Primary completion: 2003
Study completion: 2004
First posted: Jun 26, 2009
Registry last updated: Aug 19, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed