At a glance
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A Four Arm, Single-Dose, Food Effect Evaluation With 105 mg Fenofibric Acid Tablets Administered in a Fasted State and Three Different Fed Conditions, Low-Fat/Low Calorie Meal, Standard Meal, and High-Fat/High Calorie Meal
In Brief
A Phase 1 clinical trial evaluating Fenofibric Acid 105 mg Tablet for Healthy. Completed, enrolled 40 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
One 105 mg tablet administered 30 minutes after the initiation of a low-fat breakfast.
One 105 mg tablet administered 30 minutes after the initiation of a standard breakfast
One 105 mg tablet administered 30 minutes after the initiation of a high-fat/high-calorie breakfast.
One 105 mg tablet administered after an overnight fast of at least 10 hours.