Fenofibrate Bioequivalence Study (0767-031)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-02-28

Study Completion Date

2004-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Dyslipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Fenofibrate U.S. Formulation

Group Type ACTIVE_COMPARATOR

fenofibrate (U.S. formulation)

Intervention Type DRUG

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

2

Fenofibrate UK Formulation

Group Type ACTIVE_COMPARATOR

fenofibrate (UK formulation)

Intervention Type DRUG

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

Interventions

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fenofibrate (U.S. formulation)

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

Intervention Type DRUG

fenofibrate (UK formulation)

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

Intervention Type DRUG

Other Intervention Names

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Tricor® Supralip®

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes