A phase I, double blind, three-way crossover study to assess the pharmacokinetic profile of Cannabis-based medicine extract (CBME) administered sublingually in variant cannabinoid ratios in normal healthy male volunteers (GWPK0215).
A phase I, double blind, three-way crossover study to assess the pharmacokinetic profile of Cannabis-based medicine extract (CBME) administered sublingually in variant cannabinoid ratios in normal healthy male volunteers (GWPK0215).
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DOI：
10.1300/j175v03n04_02
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发表时间：
2003-01-01
期刊：
影响因子：
--
通讯作者：
Robson, P. J.
中科院分区：
文献类型：
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作者：
Guy, G. W.;Robson, P. J.
A single dose of 10 mg tetrahydrocannabinol (THC), 10 mg cannabidiol (CBD) + 10 mg THC or placebo was administered sublingually to 24 males between 18 and 50 years old. Each single dose consisted of a series of 4 actuations of 100 litre volume each (2.5 mg CBD and/or 2.5 mg THC per actuation), and each actuation was administered 5 minutes apart. All the treatments except placebo were formulated with CBME in 50% ethanol and 50% propylene glycol with peppermint flavouring. CBD and/or THC was detectable in plasma at 15-30 minutes after dosing with high THC and CBD + THC formulations. At all time points up to 180 minutes after dosing, the mean concentrations of THC were higher following THC than CBD + THC administration. Concentrations of THC were also greater than corresponding concentrations of CBD following the CBD + THC treatment. Recorded intoxication scores did not appear to have a direct relationship to plasma concentrations of THC and/or 11-hydroxy-THC either within or between subjects. The THC and CBD:THC treatments resulted in a greater number of subjects who experienced intoxication-type adverse events and application-site-type reactions. However, all the events were mild. The time to maximum THC concentration in plasma was longer following CBD + THC treatment than THC treatment; this was the only significant difference in pharmacokinetic parameters between the treatments. Considering the wide inter- and intrasubject variation in pharmacokinetic parameters, this is unlikely to be clinically important in a medication that is self-titrated by the patient.
