CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 30 enrolled
Drug / intervention
Efavirenz 600 mg +2 moredrug
Likely dose
Efavirenz 600 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.

Search/NCT00960570
NCT00960570Phase 1Completed
CompareCT.gov

An Open-Label Drug Interaction Study to Investigate the Effects of Steady State Fenofibric Acid on the Single-Dose Pharmacokinetics of Efavirenz in Healthy Volunteers

Mutual Pharmaceutical Company, Inc.·interventional·Posted Aug 18, 2009·Updated Aug 7, 2012

In Brief

A Phase 1 clinical trial evaluating Efavirenz 600 mg and Fenofibric Acid for Healthy. Completed, enrolled 30 participants.

Detailed Summary

Efavirenz is predominantly metabolized by cytochrome P450 (CYP) 2B6. Fenofibric Acid is an inhibitor of CYP 2B6. This study will evaluate the effect of multiple doses of fenofibric acid at steady-state on the pharmacokinetics of single-dose efavirenz in healthy adult subjects.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
Countries--
Collaborators--

Timeline

Phase 1CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 18, 2009
Enrollment StartFeb 1, 2008
Primary CompletionMar 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 16.9 years ago

Interventions

Efavirenz 600 mgdrug

Efavirenz 600 mg administered as a single oral dose on the morning of Day 1.

Efavirenz 600 mgdrug

Co-administered single oral doses of Efavirenz 600 mg and Fenofibric Acid 105 mg on Day 31.

Fenofibric Aciddrug

Co-administered single oral doses of Efavirenz 600 mg and Fenofibric Acid 105 mg on Day 31.