Fenofibrate Bioequivalence Study - Full Text View

Sponsor:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00928694

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 I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Crossover Assignment, Bio-equivalence Study
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:

Drug Information available for: Procetofen

U.S. FDA Resources

Further study details as provided by Merck:

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
1: Active Comparator 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.
2: Active Comparator Fenofibrate UK Formulation	Drug: fenofibrate (UK formulation) Single dose of 160 mg fenofibrate UK formulation (Supralip®) in one of two treatment periods.

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

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

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2009_606, MK0767-031
Study First Received:	June 25, 2009
Results First Received:	November 10, 2009
Last Updated:	January 11, 2010
ClinicalTrials.gov Identifier:	NCT00928694 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Antimetabolites
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Antilipemic Agents

Procetofen
Pharmacologic Actions
Dyslipidemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on February 08, 2010