At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating Fenofibric Acid 35 mg Tablet and Fenofibric Acid 105 mg Tablet for Healthy. Completed, enrolled 54 participants.
Detailed 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.
Study Details
Timeline
Interventions
1 x 35 mg tablet administered after an overnight fast of at least 10 hours
3 x 35 mg tablets administered after an overnight fast of at least 10 hours
105 mg tablet administered after an overnight fast of at least 10 hours