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Drug-Drug Interaction Study Between Fenofibric Acid and Efavirenz

NCT00960570 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2012-08-07

Study results available
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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.

Conditions

  • Healthy

Interventions

DRUG

Efavirenz 600 mg

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

DRUG

Efavirenz 600 mg

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

DRUG

Fenofibric Acid

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

Sponsors & Collaborators

  • Mutual Pharmaceutical Company, Inc.

    lead INDUSTRY

Principal Investigators

  • Anthony R Godfrey, Pharm. D · PRACS Insitute

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2008-03-31
Completion
2008-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00960570 on ClinicalTrials.gov