Fenofibrate Bioequivalence Study (0767-031)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Dyslipidemia

Treatments: Drug: fenofibrate (UK formulation); Drug: fenofibrate (U.S. formulation)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00928694

2009_606

0767-031

MK0767-031

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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14 participants in 2 patient groups

1

Active Comparator group

Description:

Fenofibrate U.S. Formulation

Treatment:

Drug: fenofibrate (U.S. formulation)

2

Active Comparator group

Description:

Fenofibrate UK Formulation

Treatment:

Drug: fenofibrate (UK formulation)