Bioequivalence Study of Fenofibric Acid Versus Tricor® (Fenofibrate)

• Status: Completed
• Trial end date: 2007-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Mutual Pharmaceutical Company, Inc.
• Treatments: Fenofibrate; Fenofibric acid

Criteria

Inclusion Criteria:

• Healthy adults 18-45 years of age

• 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

Exclusion Criteria:

• 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 fenofibrate (fenofibric acid)