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Bioequivalence Study of Fenofibric Acid Versus Tricor® (Fenofibrate)

NCT00961116 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2009-11-03

Study results available
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Summary

This study will evaluate the bioequivalence of 105 mg fenofibric acid tablets relative to 145 mg fenofibrate tablets in healthy volunteers under fasting conditions. A secondary objective is to characterize the pharmacokinetic profile of fenofibric acid when administered as a single 105 mg dose to healthy volunteers in a fasted state. Safety and tolerability of this regimen will also be evaluated.

Conditions

  • Healthy

Interventions

DRUG

Fenofibric Acid (Fibricor™) 105 mg Tablet

1 x 105 mg fenofibric acid (Fibricor™) tablet administered after an overnight fast of at least 10 hours

DRUG

Fenofibrate (Tricor®) 145 mg Tablet

1 x 145 mg Fenofibrate (Tricor®) tablet administered after an overnight fast of at least 10 hours

Sponsors & Collaborators

  • Mutual Pharmaceutical Company, Inc.

    lead INDUSTRY

Principal Investigators

  • Anthony R Godfrey, Pharm.D. · PRACS - Cetero

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2007-11-30
Completion
2007-11-30

Countries

  • United States

Study Locations

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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 NCT00961116 on ClinicalTrials.gov