Pharmacokinetic Interaction Study of Efavirenz and American Ginseng in Healthy Volunteers
Status:
Completed
Trial end date:
2011-03-14
Target enrollment:
Participant gender:
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.
Phase:
Phase 1
Details
Lead Sponsor:
Johns Hopkins University
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)