Cannabidiol as a Medication for Neuropsychiatric and Other Medical Conditions - an in Vivo Innovative Drug Delivery Study

Central Institute of Mental Health, Mannheim1 个研究点分布在 1 个国家目标入组 8 人开始时间: 2018年12月10日最近更新: 2020年7月1日

适应症

干预措施

试验速览

阶段: 1 期
状态: 终止
发起方
入组人数: 8
试验地点: 1
主要终点: Pharmacokinetic profile of multiple dosing - area under the curve (AUC(τ))

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Basic characterization of the drug delivery system for cannabidiol. A comparative bioavailability study.

详细描述

This study aims to investigate an innovative pharmaceutical preparation of cannabidiol. Thus, a comparative bioavailability study will be conducted, comparing cannabidiol capsules (reference formulation) with an intranasal cannabidiol gel (test formulation), with the further aim to find an appropriate dosing of the new pharmaceutical preparation. The intranasal administration may also be suitable to reduce the high variability in the bioavailability of cannabidiol observed for the current oral administration.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Crossover
主要目的: Basic Science
盲法: None

入排标准

年龄范围: 18 Years 至 85 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•Informed consent given by the subject
•Negative drug screening at the time of screening
•Non-smoking
•In female participants in fertile age, reliable contraception, which means contraception's Pearl index is equal to or smaller than
•Body Mass Index between 18.5 kg/m2 and 30 kg/m2

排除标准

•Lack of accountability
•Pregnancy or lactation phase in females at the time of screening
•Any known psychiatric or neurological illness in the participant's history.
•Known family history regarding psychiatric disorders with an increased lifetime risk for psychiatric disorders in the participant (investigators qualified judgement)
•Relevant use of cannabis (which is defined on the present state of knowledge as more than five times lifetime consumption and/or more than two consumptions during the last year)
•Consumption of any illicit drugs (except cannabis in history, see above)
•Severe physical (internal) or neurological illness, especially cardiovascular, renal, advanced respiratory, haematologic or endocrinologic disorders or infectious diseases (acute hepatitis A, B or C or HIV) assessed at the time of the screening by the subject's history, clinical examination and laboratory testing, as assessed by the investigator

研究组 & 干预措施

Reference formulation

Active Comparator

Cannabidiol capsule, 200 mg

干预措施: Cannabidiol (Drug)

New formulation

Experimental

Cannabidiol, intranasal gel (XX mg, dose need to be determined during the study)

干预措施: Cannabidiol (Drug)