NCT00961259

Fasted Pharmacokinetic and Bioequivalency Study of Fenofibric Acid

Open-Label, Randomized, Single-Dose, 3-Arm, Crossover Pharmacokinetic and Bioequivalence Study of One 35 mg Fenofibric Acid Tablet and Three 35 mg Fenofibric Acid Tablets Versus One 105 mg Fenofibric Acid Tablet Under Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Mutual Pharmaceutical Company, Inc. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	Fenofibric Acid 35 mg Tablet	1 x 35 mg tablet administered after an overnight fast of at least 10 hours
DRUG	Fenofibric Acid 35 mg Tablet	3 x 35 mg tablets administered after an overnight fast of at least 10 hours
DRUG	Fenofibric Acid 105 mg Tablet	105 mg tablet administered after an overnight fast of at least 10 hours

Timeline

• Start date: 2008-02-01
• Primary completion: 2008-02-01
• Completion: 2008-02-01
• First posted: 2009-08-18
• Last updated: 2012-06-08
• Results posted: 2009-11-05