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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. 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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01136928
The ClinicalTrials.gov registry entry for NCT01136928 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johns Hopkins University, which has 1,448 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which American ginseng is the first listed.
NCT01136928 reports 0 study locations.
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.
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