Clinical trial NCT00960856
Conditions: Healthy
Keywords: pharmacokinetics
Sponsor: Mutual Pharmaceutical Company, Inc.
Start date: 2007-11-01; Completion date: 2007-11-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
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.

Detailed description:
The primary objective of this study is to determine 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. Forty healthy, non-smoking, non-obese, non-pregnant adult volunteers between the ages of 18 and 45 years old will receive a single oral dose of fenofibric acid in one of four randomly assigned sequences of meal conditions each separated by a 7 day washout period. On study Days 1, 8, 15 and 22 each subject will receive a single oral dose (1 x 105 mg tablet) of fenofibric acid following an overnight fast of at least 10 hours or with a low-fat meal, standard meal, or high-fat/high-calorie meal according to their randomization sequence. Subjects will fast for at least 4.25 hours after dosing in each of the four dosing conditions. Blood samples will be drawn from all participants before dosing and for 72 hours post-dose at times sufficient to adequately define the pharmacokinetics of fenofibric acid. A further goal of this study is to evaluate the safety and tolerability of this regimen in healthy volunteers. Seated blood pressure and heart rate will be measured prior to dosing and at 2 hours post-dose. Subjects will be monitored throughout the confinement portion of the study for adverse reactions to the study drug and/or procedures. All adverse events whether elicited by query, spontaneously reported, or observed by clinic staff will be evaluated by the Investigator and reported in the subject's case report form.

Arms: arm 1: Fenofibric Acid 105 mg tablet administered 30 minutes after the initiation of a low-fat breakfast. arm 2: Fenofibric Acid 105 mg tablet administered 30 minutes after the initiation of a standard breakfast. arm 3: Fenofibric Acid 105 mg tablet administered 30 minutes after the initiation of a high-fat/high-calorie breakfast. arm 4: Fenofibric Acid 105 mg tablet administered after an overnight fast of at least 10 hours
Interventions: intervention 1: Fenofibric Acid 105 mg Tablet intervention 2: Fenofibric Acid 105 mg Tablet intervention 3: Fenofibric Acid 105 mg Tablet intervention 4: Fenofibric Acid 105 mg Tablet
Intervention descriptions: intervention 1: One 105 mg tablet administered 30 minutes after the initiation of a low-fat breakfast. intervention 2: One 105 mg tablet administered 30 minutes after the initiation of a standard breakfast intervention 3: One 105 mg tablet administered 30 minutes after the initiation of a high-fat/high-calorie breakfast. intervention 4: One 105 mg tablet administered after an overnight fast of at least 10 hours.

Protocol documents: