| Outcome Measures: |
Primary: Pharmacokinetic parameters of THC: Cmax, AUC(0-t) and AUC(0-∞), The following are presented for THC: * Mean maximum (peak) plasma concentration of the drug (Cmax) * Mean area under the concentration-time curve calculated to the last observable concentration at time t (AUC(0-t)) * Mean area under the concentration-time curve from time zero to infinity (AUC(0-∞)), Pre-dose (t=0) and up to 48 hours post-dose|Pharmacokinetic parameters of 11-hydroxy-THC (11-OH-THC): Cmax, AUC(0-t) and AUC(0-∞), The following are presented for 11-OH-THC: * Mean Cmax * Mean AUC(0-t) * Mean AUC(0-∞), Pre-dose (t=0) and up to 48 hours post-dose|Pharmacokinetic parameters of CBD: Cmax, AUC(0-t) and AUC(0-∞), The following are presented for CBD: * Mean Cmax * Mean AUC(0-t) * Mean AUC(0-∞), Pre-dose (t=0) and up to 48 hours post-dose|Pharmacokinetic parameters of 7-hydroxy-CBD (7-OH-CBD): Cmax, AUC(0-t) and AUC(0-∞), The following are presented for 7-OH-CBD: * Mean Cmax * Mean AUC(0-t) * Mean AUC(0-∞), Pre-dose (t=0) and up to 48 hours post-dose | Secondary: Pharmacokinetic parameters of THC: t(1/2), tmax, CL/F, CLr and F(e,u), The following are presented for THC; * Mean terminal-phase elimination half-life (t(1/2)) * Mean time to maximum (peak) plasma concentration (tmax) * Mean apparent clearance of drug from plasma (CL/F) * Mean renal clearance (CLr) * Mean fraction of the systemically available drug excreted into the urine (F(e,u)), Pre-dose (t=0) and up to 48 hours post-dose|Pharmacokinetic parameters of 11-OH-THC: t(1/2), tmax, CLr and F(e,u), The following are presented for 11-OH-THC; * Mean t(1/2) * Mean tmax * Mean CLr * Mean F(e,u), Pre-dose (t=0) and up to 48 hours post-dose|Pharmacokinetic parameters of CBD: t(1/2), tmax, CL/F, CLr and F(e,u), The following are presented for CBD; * Mean t(1/2) * Mean tmax * Mean CL/F * Mean CLr * Mean F(e,u), Pre-dose (t=0) and up to 48 hours post-dose|Pharmacokinetic parameters of 7-OH-CBD: t(1/2), tmax, CLr and F(e,u), The following are presented for 7-OH-CBD; * Mean t(1/2) * Mean tmax * Mean CLr * Mean F(e,u), Pre-dose (t=0) and up to 48 hours post-dose|Pharmacokinetic parameters of THC: Cmax(u), AUC(0-t(u)), AUC(0-∞(u)) and CLu/F, The following are presented for THC: * Mean unbound maximum (peak) plasma concentration of the drug (Cmax(u)) * Mean unbound area under the concentration-time curve calculated to the last observable concentration at time t (AUC(0-t(u))) * Mean unbound area under the concentration-time curve from time zero to infinity (AUC(0-∞(u))) * Mean apparent unbound clearance of drug from plasma (CLu/F), Pre-dose (t=0) and up to 48 hours post-dose|Pharmacokinetic parameters of 11-OH-THC: Cmax(u), AUC(0-t(u)) and AUC(0-∞(u)), The following are presented for 11-OH-THC: * Mean Cmax(u) * Mean AUC(0-t(u)) * Mean AUC(0-∞(u)), Pre-dose (t=0) and up to 48 hours post-dose|Pharmacokinetic parameters of CBD: Cmax(u), AUC(0-t(u)), AUC(0-∞(u)) and CLuF, The following are presented for CBD: * Mean Cmax(u) * Mean AUC(0-t(u)) * Mean AUC(0-∞(u)) * Mean CLu/F, Pre-dose (t=0) and up to 48 hours post-dose|Pharmacokinetic parameters of 7-OH-CBD: Cmax(u), AUC(0-t(u)) and AUC(0-∞(u)), The following are presented for 11-OH-THC: * Mean Cmax(u) * Mean AUC(0-t(u)) * Mean AUC(0-∞(u)), Pre-dose (t=0) and up to 48 hours post-dose|The incidence of adverse events as a measure of subject safety, The number of subjects who experienced an adverse event during the study is presented. The time-frame for adverse event reporting was from screening to the follow-up visit., From screening to follow-up (a maximum of 24 days)|The number of subjects with a clinically significant change in physical and oral examination results, relative to pre-treatment baseline, The number of subjects with a change in physical and oral examination results indicative of an adverse event, relative to the pre-treatment baseline, is presented., From screening to follow-up (a maximum of 24 days)|The number of subjects with a clinically significant change in 12-lead electrocardiogram (ECG) results, relative to pre-treatment baseline, The number of subjects with a change in ECG results indicative of an adverse event, relative to the pre-treatment baseline, is presented., From screening to follow-up (a maximum of 24 days)|The number of subjects with clinically significant changes in laboratory test parameters, relative to pre-treatment baseline, The number of subjects with clinically significant changes in serum biochemistry, hematology and urinalysis, relative to the pretreatment baseline, is presented., From screening to follow-up (a maximum of 24 days)|The number of subjects with a clinically significant change in vital signs, relative to pre-treatment baseline, The number of subjects with a clinically significant change in vital signs (systolic blood pressure, diastolic blood pressure, pulse rate) indicative of an adverse event, relative to the pre-treatment baseline, is presented. A clinically significant drop in blood pressure is defined as a 20 mmHg drop in systolic or 10 mmHg drop in diastolic blood pressure associated with a clinical manifestation of postural hypotension after two minutes standing., From screening to follow-up (a maximum of 24 days)
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