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Four Arm Food Effect Study of Fenofibric Acid Tablets

NCT00960856 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2009-10-20

Study results available
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Summary

The primary objective of this study is to characterize the single-dose pharmacokinetic profile of fenofibric acid (105 mg tablets) and the effect of food of various calorie/fat compositions on the rate and extent of absorption. Additionally, the safety and tolerability of this dose and regimen of fenofibric acid will be evaluated.

Conditions

  • Healthy

Interventions

DRUG

Fenofibric Acid 105 mg Tablet

One 105 mg tablet administered 30 minutes after the initiation of a low-fat breakfast.

DRUG

Fenofibric Acid 105 mg Tablet

One 105 mg tablet administered 30 minutes after the initiation of a standard breakfast

DRUG

Fenofibric Acid 105 mg Tablet

One 105 mg tablet administered 30 minutes after the initiation of a high-fat/high-calorie breakfast.

DRUG

Fenofibric Acid 105 mg Tablet

One 105 mg tablet administered after an overnight fast of at least 10 hours.

Sponsors & Collaborators

  • Mutual Pharmaceutical Company, Inc.

    lead INDUSTRY

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
2007-11-30
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 NCT00960856 on ClinicalTrials.gov