Bioavailability and Metabolism of Voriconazole as a Function of the CYP2C19 Genotype

Heidelberg University1 个研究点分布在 1 个国家目标入组 24 人开始时间: 2005年7月最近更新: 2007年4月17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: 24
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

The purposes of this study are:

To determine the absolute bioavailability of voriconazole after a single oral dose (400 mg voriconazole [VFEND brand]) in comparison to intravenous (i.v.) administration (400 mg VFEND, equivalent to two 10 mg/ml-infusates, each containing 200 mg voriconazole [VRC]) in healthy individuals stratified according to the three predominant CYP2C19 genotypes
To investigate the possible pathways of metabolism and their modulation according to genetic polymorphism of CYP2C19 after i.v. and oral administration of VRC.

详细描述

As CYPs are mainly involved in VRC metabolism it is likely that also gut wall metabolism by CYPs occurs. However, no substantial first pass metabolism of VRC has been reported. In humans the VRC metabolism has not been studied systematically. It is therefore important to assess VRC metabolism on its own and in addition the influence of CYP2C19 genetic polymorphisms on the formation of the different VRC metabolites.

研究设计

研究类型: Observational
观察模型: Defined Population
时间视角: Other

入排标准

年龄范围: 18 Years 至 50 Years（Adult）
性别: All
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 except for oral contraceptives in female participants
•Any intake of a substance known to induce or inhibit drug metabolising enzymes or transport system enzymes 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 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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