A Single Centre, Placebo-Controlled, Four Period, Crossover, Tolerability Study Assessing, Pharmacodynamic Effects, Pharmacokinetic Characteristics and Cognitive Profiles of a Single Dose of Three Formulations of Cannabis Based Medicine Extracts (CBMEs) (GWPD9901), Plus a Two Period Tolerability Study Comparing Pharmacodynamic Effects and Pharmacokinetic Characteristics of a Single Dose of a Cannabis Based Medicine Extract Given via Two Administration Routes (GWPD9901 EXT)

Abstract

SUMMARY This study was the first study of GW's CBME in man. It was performed in six healthy subjects, employing test treatments consisting of CBD:THC sublingual drops (GW-1011-01): 5 mg Δ9-tetrahydrocannabinol (THC) + 5 mg cannabidiol (CBD) per ml of glycerol:ethanol (Eth):propylene glycol (PG) (4:4:2), with peppermint flavouring, High CBD sublingual drops (GW-3009-01): 5 mg CBD per ml of glycerol: Eth:PG (4:4:2), with peppermint flavouring, High THC sublingual drops (GW-2009-01): 5 mg THC per ml of glycerol:Eth:PG (4:4:2), with peppermint flavouring, placebo sublingual drops (GW-4003-01): glycerol: Eth:PG (4:4:2), with peppermint flavouring, aerosol (GW-1009-01): 5 mg CBD + 5 mg THC per ml formulated in propellant:Eth (80:20), and nebuliser (GW-1012-01): 10 mg CBD + 10 mg THC per ml of cremophor (Crem) (0.4):PG (1.5):macrogol (1):dodecanol (0.8):H2O (7.4), and placebo nebuliser (administered to subjects 005 and 006 instead of the active nebuliser test treatment): Crem (0.4):PG (1.5):macrogol (1):dodecano...