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Fenofibrate Bioequivalence Study (0767-031)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00928694
First Posted: June 26, 2009
Last Update Posted: August 19, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  Purpose
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.

Condition Intervention Phase
Dyslipidemia Drug: fenofibrate (U.S. formulation) Drug: fenofibrate (UK formulation) Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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 ]

Enrollment: 14
Study Start Date: February 2003
Study Completion Date: April 2004
Primary Completion Date: April 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Supralip®

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00928694


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00928694     History of Changes
Other Study ID Numbers: 0767-031
MK0767-031
2009_606
First Submitted: June 25, 2009
First Posted: June 26, 2009
Results First Submitted: November 10, 2009
Results First Posted: December 11, 2009
Last Update Posted: August 19, 2015
Last Verified: August 2015

Additional relevant MeSH terms:
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Fenofibrate
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents