A Randomised, Open-label, Three-way Crossover Study to Assess the Pharmacokinetics and Safety of Single Doses of Four Sprays of Sativex® in a Range of Oral pH Environments in Healthy Subjects

PHASE1TerminatedINTERVENTIONAL
Enrollment

6

Participants

Timeline

Start Date

August 31, 2014

Primary Completion Date

August 31, 2014

Study Completion Date

October 31, 2015

Conditions
Healthy Volunteers
Interventions
DRUG

Sativex

Oromucosal spray containing THC (27 mg/mL) and CBD (25 mg/mL) in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavouring. Each 100 μL spray delivers 2.7 mg THC and 2.5 mg CBD.

Sponsors
All Listed Sponsors
lead

GW Pharmaceuticals Ltd

INDUSTRY