Pharmacokinetics of 11-Nor-9-carboxy-D9-tetrahydrocannabinol (THCCOOH) and Its Acyl-glucuronide (THCCOOH-GLu) After Intravenous Administration of THCCOOH in Healthy Human Subjects

Heidelberg University1 个研究点分布在 1 个国家目标入组 10 人开始时间: 2004年10月最近更新: 2015年5月28日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: Heidelberg University
入组人数: 10
试验地点: 1

研究概览研究设计入排标准研究者研究点记录与标识符相似试验

研究概览

简要总结

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

详细描述

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)

研究设计

研究类型: Observational
时间视角: Prospective

入排标准

年龄范围: 18 Years 至 50 Years（Adult）
性别: Male
接受健康志愿者: 是

入选标准

•Good state of health (physically and mentally)

排除标准

•Any regular drug treatment within the last two months
•Any intake of a substance known to induce or inhibit drug metabolising enzymes or transport systems within a period of less than 10 times the respective elimination half-life
•Any acute or chronic illness or clinically relevant findings in the pre-study examination
•Allergies (except for mild forms of hay fever) or history of hypersensitivity reactions
•Smoking (regular or irregular)
•Excessive alcohol drinking (more than approximately 30 g alcohol per day)
•Positive drug screening especially THC or known or admitted drug abuse

研究者

发起方

Heidelberg University

申办方类型

Other

研究点 (1)

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