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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 is a Phase 1 study that has completed, run by Jazz Pharmaceuticals. The registered enrollment target is 14 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02325011
The ClinicalTrials.gov registry entry for NCT02325011 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Jazz Pharmaceuticals, which has 128 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Sativex® (Treatment A) is the first listed.
NCT02325011 reports 0 study locations.
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.
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