An Study to Evaluate the Effects of Fluconazole on the Pharmacokinetics (PK) of Sativex® in Healthy Subjects With Cannabis Experience.

PHASE1CompletedINTERVENTIONAL
Enrollment

14

Participants

Timeline

Start Date

November 30, 2014

Primary Completion Date

February 28, 2015

Study Completion Date

February 28, 2015

Conditions
Healthy Subjects
Interventions
DRUG

Sativex® (Treatment A)

Each 100 uL actuation (spray) of Sativex contains 27 mg/mL THC and 25 mg/mL CBD plus peppermint flavouring. The study dosage of 10.8 mg THC and 10 mg CBD is delivered as four sprays to the oral mucosa.

DRUG

Sativex® and fluconazole concomitantly (Treatment B)

"Each 100 uL actuation (spray) of Sativex contains 27 mg/mL THC and 25 mg/mL CBD plus peppermint flavouring. The study dosage of 10.8 mg THC and 10 mg CBD is delivered as four sprays to the oral mucosa.~Fluconazole 200 mg twice daily (BID) for two days, will be administered at the following time points relative to the Day 1 Sativex dose: 1 hour pre-dose, and approximately 11, 24, and 36 hours post-dose."

Trial Locations (1)

92801

Anaheim Clinical Trials, Anaheim

Sponsors
All Listed Sponsors
lead

Jazz Pharmaceuticals

INDUSTRY