Fenofibrate Bioequivalence Study (0767-031)

Dyslipidemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00928694
• Other study ID #: 0767-031
• Secondary ID: MK0767-0312009_6
• Status: Completed
• Phase: Phase 1
• First received: June 25, 2009
• Last updated: August 18, 2015
• Start date: February 2003
• Est. completion date: April 2004

Study information

• Verified date: August 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: April 2004
• Est. primary completion date: April 2003
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias

Intervention

Drug:
• fenofibrate (U.S. formulation)
Single dose of 160 mg fenofibrate U.S. formulation (Tricor®) in one of two treatment periods.
• fenofibrate (UK formulation)
Single dose of 160 mg fenofibrate UK formulation (Supralip®) in one of two treatment periods.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area Under the Curve (AUC(0 to Infinity)) of Fenofibric Acid		Predose and up to 168 hours postdose	No
Primary	Maximum Plasma Concentration (Cmax) of Fenofibric Acid		Predose and up to 168 hours postdose	No