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NCT01136928 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetic Interaction Study of Efavirenz and American Ginseng in Healthy Volunteers
A Phase 1 study, sponsored by Johns Hopkins University.
- Completed
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
NCT01136928: Completed Phase 1 study, sponsored by Johns Hopkins University.
NCT01136928 is a Phase 1 study that has completed, run by Johns Hopkins University. The registered enrollment target is 15 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01136928, a Phase 1 study, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
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.
Primary Outcome
Compare efavirenz AUC0-24 and Cmax when dosed alone at 600 mg daily, to steady-state efavirenz AUC0-24 and Cmax dosed at 600 mg daily and given concurrently with American ginseng 3000 mg daily.
Interventions
- DRUG American ginseng
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2010-09-28 |
| Est. Completion | 2011-03-14 |
| Phase | Phase 1 |
What the finished NCT01136928 record still lists
NCT01136928 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 1 intervention - of which American ginseng is the first listed.
NCT01136928 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01136928 about?
NCT01136928 is a clinical study titled "Pharmacokinetic Interaction Study of Efavirenz and American Ginseng in Healthy Volunteers". 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 als...
What is the current status of trial NCT01136928?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2010-09-28. Estimated completion is 2011-03-14.
What interventions are being tested in trial NCT01136928?
The interventions under investigation include: American ginseng (DRUG).
Who is sponsoring clinical trial NCT01136928?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01136928's enrollment target sits among peer trials
15 1798th of 2000 higher than 157 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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