At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 14 enrolled
Drug / intervention
fenofibrate (U.S. formulation) +1 moredrug
Likely dose
fenofibrate (U.S. formulation) 160 mgfrom 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.
An Open-Label, Randomized, 2-Period, Crossover Study to Determine Definitive Bioequivalence After Administration of Single 160 mg Doses of the U.S. and UK Formulations of Fenofibrate in Healthy Adult Subjects
In Brief
A Phase 1 clinical trial evaluating fenofibrate (U.S. formulation) and fenofibrate (UK formulation) for Dyslipidemia. Completed, enrolled 14 participants.
Detailed Summary
This study will determine definitive bioequivalence of the United States (U.S.) and United Kingdom (UK) formulations of fenofibrate following administration of single doses in healthy adult subjects.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDyslipidemia
Countries--
Collaborators--
Timeline
Phase 1CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartFeb 2003
Primary CompletionApr 2003
Study CompletionApr 2004
First PostedJun 2009
TodayJul 2026
First PostedJun 26, 2009
Enrollment StartFeb 1, 2003
Primary CompletionApr 1, 2003
Study CompletionApr 1, 2004
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 17.0 years ago
Interventions
fenofibrate (U.S. formulation)drug
Single dose of 160 mg fenofibrate U.S. formulation (Tricor®) in one of two treatment periods.
fenofibrate (UK formulation)drug
Single dose of 160 mg fenofibrate UK formulation (Supralip®) in one of two treatment periods.