Fenofibrate Bioequivalence Study (0767-031)

August 18, 2015 updated by: Merck Sharp & Dohme LLC

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Fenofibrate U.S. Formulation
Drug: fenofibrate (U.S. formulation)
Single dose of 160 mg fenofibrate U.S. formulation (Tricor®) in one of two treatment periods.
Other Names:
  • Tricor®
Active Comparator: 2
Fenofibrate UK Formulation
Drug: fenofibrate (UK formulation)
Single dose of 160 mg fenofibrate UK formulation (Supralip®) in one of two treatment periods.
Other Names:
  • Supralip®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Area Under the Curve (AUC(0 to Infinity)) of Fenofibric Acid
Time Frame: Predose and up to 168 hours postdose
Predose and up to 168 hours postdose
Maximum Plasma Concentration (Cmax) of Fenofibric Acid
Time Frame: Predose and up to 168 hours postdose
Predose and up to 168 hours postdose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2003

Primary Completion (Actual)

April 1, 2003

Study Completion (Actual)

April 1, 2004

Study Registration Dates

First Submitted

June 25, 2009

First Submitted That Met QC Criteria

June 25, 2009

First Posted (Estimate)

June 26, 2009

Study Record Updates

Last Update Posted (Estimate)

August 19, 2015

Last Update Submitted That Met QC Criteria

August 18, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0767-031
  • MK0767-031
  • 2009_606

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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