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Pharmacokinetic Interaction Study of Efavirenz and American Ginseng in Healthy Volunteers

NCT01136928 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2018-06-15

No results posted yet for this study

Summary

This is a 4-week sequential drug interaction study to measure the effects of American ginseng on efavirenz pharmacokinetics using steady-state 24-hour Area Under the Curve (AUC) and Cmax as the primary comparison measures in healthy male volunteers. Efavirenz Cmin, T1/2, tmax, and clearance will also be assessed as secondary outcome measures. This study is a phase I, prospective, within-subject, fixed-order, two-period, multiple dose, open label, drug interaction study, to determine the stead-state plasma pharmacokinetic profile of efavirenz before and after concurrent treatment with American ginseng. The investigators hypothesis is that concurrent oral administration of American ginseng for up to 14 days will not significantly alter the steady-state plasma pharmacokinetic of efavirenz.

Conditions

  • Healthy Volunteers

Interventions

DRUG

American ginseng

Healthy volunteers will ge given efavirnez 600 mg daily monotherapy for 14 days followed by efavirenz 600 mg PLUS American ginseng 3000 mg daily for an additional 14 days.

Sponsors & Collaborators

Principal Investigators

  • Adriana Andrade, MD, MPH · Johns Hopkins University

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-09-28
Primary Completion
2011-03-14
Completion
2011-03-14

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT01136928 on ClinicalTrials.gov