Fenofibrate Bioequivalence Study (0767-031)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00928694
First received: June 25, 2009
Last updated: May 8, 2014
Last verified: May 2014
  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
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: 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 ] [ Designated as safety issue: No ]
  • Maximum Plasma Concentration (Cmax) of Fenofibric Acid [ Time Frame: Predose and up to 168 hours postdose ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00928694

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

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00928694     History of Changes
Other Study ID Numbers: 0767-031, MK0767-031, 2009_606
Study First Received: June 25, 2009
Results First Received: November 10, 2009
Last Updated: May 8, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 16, 2014