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/NCT00960687
NCT00960687Phase 1Completed
CompareCT.gov

A Single-Dose, Bioequivalence Study of 105 mg Fenofibric Acid Tablets Versus 145 mg TriCor® (Fenofibrate) Tablets Under Fed Conditions(Standard Meal)

Mutual Pharmaceutical Company, Inc.·interventional·Posted Aug 18, 2009·Updated Oct 20, 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.

Detailed Summary

This study will evaluate the bioequivalence of 105 mg fenofibric acid tablets relative to 145 mg fenofibrate tablets in healthy volunteers when administered following a breakfast of standard composition. Safety and tolerability of this regimen will also be evaluated.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
Countries--
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 30 minutes after the initiation of a standard breakfast.

Fenofibrate (Tricor®) 145 mg Tabletdrug

1 x 145 mg Fenofibrate (Tricor®) tablet administered 30 minutes after the start of a standard breakfast.