Status:

COMPLETED

Fenofibrate Bioequivalence Study (0767-031)

Lead Sponsor:

Merck Sharp & Dohme LLC

Conditions:

Dyslipidemia

Eligibility:

All Genders

18-45 years

Phase:

PHASE1

Brief 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.

Eligibility Criteria

Inclusion

  • Subject is in good health
  • Subject is willing to follow all study guidelines

Exclusion

  • 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

Key Trial Info

Start Date :

February 1 2003

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

April 1 2004

Estimated Enrollment :

14 Patients enrolled

Trial Details

Trial ID

NCT00928694

Start Date

February 1 2003

End Date

April 1 2004

Last Update

August 19 2015

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