CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 54 enrolled
Drug / intervention
Fenofibric Acid (Fibricor™) 105 mg Tablet +1 moredrug
Likely dose
Fenofibric Acid (Fibricor™) 105 mg Tabletfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00961116
NCT00961116Phase 1Completed
CompareCT.gov

A Single-Dose, Bioequivalence Study of 105 mg Fenofibric Acid Tablets Versus 145 mg Tricor® (Fenofibrate) Tablets Under Fasting Conditions.

Mutual Pharmaceutical Company, Inc.·interventional·Posted Aug 18, 2009·Updated Nov 3, 2009

In Brief

A Phase 1 clinical trial evaluating Fenofibric Acid (Fibricor™) 105 mg Tablet and Fenofibrate (Tricor®) 145 mg Tablet for Healthy. Completed, enrolled 54 participants across 1 site.

Detailed Summary

This study will evaluate the bioequivalence of 105 mg fenofibric acid tablets relative to 145 mg fenofibrate tablets in healthy volunteers under fasting conditions. A secondary objective is to characterize the pharmacokinetic profile of fenofibric acid when administered as a single 105 mg dose to healthy volunteers in a fasted state. Safety and tolerability of this regimen will also be evaluated.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 18, 2009
Enrollment StartOct 1, 2007
Primary CompletionNov 1, 2007
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 16.9 years ago

Interventions

Fenofibric Acid (Fibricor™) 105 mg Tabletdrug

1 x 105 mg fenofibric acid (Fibricor™) tablet administered after an overnight fast of at least 10 hours

Fenofibrate (Tricor®) 145 mg Tabletdrug

1 x 145 mg Fenofibrate (Tricor®) tablet administered after an overnight fast of at least 10 hours