Pharmacokinetics Clinical Trial
Official title:
Pharmacokinetics of 11-Nor-9-carboxy-D9-tetrahydrocannabinol (THCCOOH) and Its Acyl-glucuronide (THCCOOH-GLu) After Intravenous Administration of THCCOOH in Healthy Human Subjects
A study on the fate and elimination of 11-Nor-Delta9-carboxy-9-tetrahydrocannabinol was up
to now not conducted, except of one single experiment in which (lacking)
psychopharmacological activity was tested after intravenous infusion of 20 mg in a human
individual. In this study, however, the authors did not trace the above questions due to
analytical and methodological deficits.
Aim of the study is to determine the pharmacokinetics of THCCOOH and THCCOOH-Glu after
intravenous ad-ministration of 5 mg THCCOOH in healthy individuals
To determine the pharmacokinetics of THCCOOH after intravenous administration of THCCOOH (5
mg) and its formed glucuronide in healthy individuals in order to improve the possibilities
for the assessment of unfitness to drive. For these purposes the following criteria will be
studied:
THCCOOH
- Primary: Area under the plasma concentration time curve (AUCtotal) Maximal plasma
concentrations (Cmax) Time of Cmax (tmax) Terminal elimination half-life (t1/2)
- Secondary: Systemic and renal clearance (Cls, CLr) Volume of distribution of (Vc)
Formed THCCOOH-glu
- Primary: Area under the plasma concentration time curve (AUCtotal) Maximal plasma
concentrations (Cmax) Time of Cmax (tmax) Terminal elimination half-life (t1/2)
- Secondary: Systemic and renal clearance (Cls, CLr) Volume of distribution (Vc)
;
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