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NCT02325011 · ClinicalTrials.gov registry record · Phase 1
An Study to Evaluate the Effects of Fluconazole on the Pharmacokinetics (PK) of Sativex® in Healthy Subjects With Cannabis Experience.
A Phase 1 study, sponsored by Jazz Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 14
- Enrollment target
NCT02325011: Completed Phase 1 study, sponsored by Jazz Pharmaceuticals.
NCT02325011 is a Phase 1 study that has completed, run by Jazz Pharmaceuticals. The registered enrollment target is 14 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02325011, a Phase 1 study, has completed, sponsored by Jazz Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 14 participants
- Enrollment target
Study Summary
The study aims to evaluate the effect of fluconazole on the pharmacokinetic (PK) profile of a single oromucosal dose of Sativex® (i.e. how the body absorbs, distributes, metabolises and excretes the drug) in healthy subjects with a history of cannabis use. The primary clinical hypothesis is that no drug-drug interaction between Sativex® and fluconazole will be detected as effects on PK parameters of Sativex®, when both are administered to healthy human volunteers who have experience using cannabis. The study additionally aims to evaluate the safety and tolerability of an oromucosal dose of Sativex® in subjects when given concurrently with fluconazole.
Primary Outcome
The following are presented for THC: * Mean maximum (peak) plasma concentration of the drug (Cmax) * Mean area under the concentration-time curve calculated to the last observable concentration at time t (AUC(0-t)) * Mean area under the concentration-time curve from time zero to infinity (AUC(0-∞))
Interventions
- DRUG Sativex® (Treatment A)
- DRUG Sativex® and fluconazole concomitantly (Treatment B)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2014-11 |
| Est. Completion | 2015-02 |
| Phase | Phase 1 |
What the finished NCT02325011 record still lists
NCT02325011 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 2 interventions - of which Sativex® (Treatment A) is the first listed.
NCT02325011 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02325011 about?
NCT02325011 is a clinical study titled "An Study to Evaluate the Effects of Fluconazole on the Pharmacokinetics (PK) of Sativex® in Healthy Subjects With Cannabis Experience.". The study aims to evaluate the effect of fluconazole on the pharmacokinetic (PK) profile of a single oromucosal dose of Sativex® (i.e. how the body absorbs, distributes, metabolises and excretes the drug) in healthy subjects with a history of cannabis use. The primary clinical hypothesis is that no...
What is the current status of trial NCT02325011?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2014-11. Estimated completion is 2015-02.
What interventions are being tested in trial NCT02325011?
The interventions under investigation include: Sativex® (Treatment A) (DRUG), Sativex® and fluconazole concomitantly (Treatment B) (DRUG).
Who is sponsoring clinical trial NCT02325011?
This trial is sponsored by Jazz Pharmaceuticals, which has 128 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02325011's enrollment target sits among peer trials
14 1844th of 2000 higher than 154 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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