Four Arm Food Effect Study of Fenofibric Acid Tablets

Completed · Phase 1

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT00960856

Run by

Mutual Pharmaceutical Company, Inc.

People needed

40

Starts

2007-11-01

Expected to finish

2007-11-01

Last updated by the study team

2009-10-20

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy adults between the ages of 18 and 45
• Non-smoking
• Non-pregnant (post-menopausal, surgically sterile, or using effective contraceptive measures)
• Body mass index (BMI) less than 30
• Medically healthy on the basis of medical history and physical examination
• Hemoglobin > or = to 12g/dL
• Completion of the screening process within 28 days prior to dosing
• Provision of voluntary written informed consent

You may not qualify if…

• Recent participation (within 28 days) in other research studies
• Recent significant blood donation or plasma donation
• Pregnant or lactating
• Test positive at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HbsAg), or hepatitis C virus (HCV)
• Recent (2-year) history or evidence of alcoholism or drug abuse
• History or presence of significant cardiovascular, pulmonary, hepatic, gallbladder or biliary tract, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease
• Subjects who have used any drugs or substances known to inhibit or induce cytochrome (CYP) P450 enzymes and/or P-glycoprotein (P-gp) within 28 days prior to the first dose and throughout the study
• Drug allergies to fenofibric acid

Where it is running

• PRACS Institute, Ltd. - Cetero Research — Fargo, North Dakota, United States

Full record on ClinicalTrials.gov

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