Pharmacokinetic Interaction Study of Efavirenz and American Ginseng in Healthy Volunteers (NCT01136928) | Clinical Trial Compass
CompletedPhase 1
Pharmacokinetic Interaction Study of Efavirenz and American Ginseng in Healthy Volunteers
United States15 participantsStarted 2010-09-28
Plain-language 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.
Who can participate
Age range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. All enrollees will be healthy volunteers, ≥18 years of age with
. Negative HIV-1 serology, documented by any licensed ELISA test kit
. Ability and willingness to provide a signed informed consent and comply with study requirements
. Males only because efavirenz has been reported to have teratogenic properties
. Estimated creatinine clearance ≥50 mL/minute, as calculated by the Cockcroft-Gault method
. Normal laboratory and physical examination, as judged by the Principal Investigator
. Good peripheral venous access
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To compare efavirenz AUC0-24 and Cmax when dosed alone to steady-state efavirenz AUC0-24 and Cmax given concurrently with American ginseng. Efavirenz AUC0-24 with and without American ginseng
Timeframe: 14 days of efavirenz alone, followed by 14 days of concurrent administration of efavirenz and American ginseng
. Willingness and ability to take oral medications.
Exclusion criteria
. Known or suspected hypersensitivity to American Ginseng (AG) or efavirenz
. Taking any prescription, over-the-counter medication, or Complementary and alternative medicine (CAM) agents within 30 days of study enrolment
. Evidence of active drug or alcohol abuse
. Any other medical or psychological condition that might, in the opinion of the investigator, interfere with participation in the study or put subjects at undue risk
. Hospitalization or therapy for serious illness within 30 days prior to study entry, as judged by the investigator
. Participation in any investigational drug trials within 30 days prior to study entry that, in the opinion of the investigator, would preclude study participation.