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Fasted Pharmacokinetic and Bioequivalency Study of Fenofibric Acid

NCT00961259 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2012-06-08

Study results available
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Summary

This study will evaluate the pharmacokinetic linearity of a single 35 mg fenofibric acid dose and demonstrate the bioequivalence of three 35 mg fenofibric acid tablets (105 mg total single dose) to a single 105 mg fenofibric acid tablet in healthy adult volunteers when each dose is administered under fasted conditions. Safety and tolerability of these regimens will also be evaluated.

Conditions

  • Healthy

Interventions

DRUG

Fenofibric Acid 35 mg Tablet

1 x 35 mg tablet administered after an overnight fast of at least 10 hours

DRUG

Fenofibric Acid 35 mg Tablet

3 x 35 mg tablets administered after an overnight fast of at least 10 hours

DRUG

Fenofibric Acid 105 mg Tablet

105 mg 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 Institute

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
2008-02-29
Primary Completion
2008-02-29
Completion
2008-02-29

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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 NCT00961259 on ClinicalTrials.gov