Fasted Pharmacokinetic and Bioequivalency Study of Fenofibric Acid

NCT ID: NCT00961259

Last Updated: 2012-06-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-29
• Study Completion Date: 2008-02-29

Brief 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.

Detailed Description

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. Fifty-four healthy, non-smoking, non-obese, 18-45 year old, male and female volunteers will be randomly assigned in a crossover fashion to receive each of three fenofibric acid dosing regimens in sequence with a 7 day washout period between dosing periods. On the morning of the first day of each dosing period, after an overnight fast of at least 10 hours, subjects will receive single doses of fenofibric acid (1 x 35 mg tablet), fenofibric acid (3 x 35 mg tablets - 105 mg total dose), or fenofibric acid (1 x 105 mg tablet). Fasting will continue for 4 hours after dose administration. Blood samples will be drawn from all participants prior to dosing and for 72 hours post-dose, at times sufficient to adequately define fenofibric acid pharmacokinetics. Subjects will be monitored throughout their participation for adverse reactions to the study drug and/or procedures. Seated blood pressure and pulse will be measured prior to each dose and approximately 2 hours after each dose to coincide with peak plasma concentrations. All adverse experiences, whether elicited by query, spontaneously reported, or observed by clinic staff, will be documented in the subject's case report form.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Fenofibric Acid 35 mg (1 x 35 mg tab)

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

Group Type: EXPERIMENTAL

Fenofibric Acid 35 mg Tablet

Intervention Type: DRUG

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

Fenofibric Acid 105 mg (3 x 35 mg tab)

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

Group Type: EXPERIMENTAL

Fenofibric Acid 35 mg Tablet

Intervention Type: DRUG

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

Fenofibric Acid 105 mg (1 x 105 mg tab)

1 x 105 mg tablet administered after an overnight fast of at least 10 hours

Group Type: EXPERIMENTAL

Fenofibric Acid 105 mg Tablet

Intervention Type: DRUG

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

Interventions

Fenofibric Acid 35 mg Tablet

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

Intervention Type: DRUG

Fenofibric Acid 35 mg Tablet

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

Intervention Type: DRUG

Fenofibric Acid 105 mg Tablet

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

Intervention Type: DRUG

Eligibility 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 fenofibric acid

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mutual Pharmaceutical Company, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anthony R Godfrey, Pharm.D.

Role: PRINCIPAL_INVESTIGATOR

PRACS Institute

Other Identifiers

R08-0057

Identifier Type: -

Identifier Source: secondary_id

MPC-028-08-1017

Identifier Type: -

Identifier Source: org_study_id