Overview

Fed Bioequivalence Study of Fenofibric Acid Versus TriCorĀ® (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 when administered following a breakfast of standard composition. 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)