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Fenofibrate Bioequivalence Study (0767-031)

NCT00928694 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2015-08-19

Study results available
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Summary

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.

Conditions

Interventions

DRUG

fenofibrate (U.S. formulation)

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

DRUG

fenofibrate (UK formulation)

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

Sponsors & Collaborators

Principal Investigators

  • Medical Monitor · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2003-02-28
Primary Completion
2003-04-30
Completion
2004-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00928694 on ClinicalTrials.gov