临床试验/NCT01421706

NCT01421706已完成1 期

Effects of Clopidogrel and Clarithromycin on the Disposition of Sibutramine and Its Active Metabolites M1 and M2 in Relation to CYP2B6*6 Polymorphism

Inje University0 个研究点目标入组 20 人开始时间: 2008年7月最近更新: 2012年9月18日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Inje University
入组人数: 20
主要终点: effects of clopidogrel and clarithromycin on the disposition of sibutramine

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记录与标识符相似试验

研究概览

简要总结

Effects of clopidogrel and clarithromycin on the oral disposition of sibutramine in healthy subjects

详细描述

Plasma concentrations of sibutramine and its two active metabolites after single oral dose of sibutramine were determined in Korean healthy male subjects with different CYP2B6 genotypes (CYP2B6*1/*1, *1/*6 and *6/*6), either alone or after four-day pretreatment with clopidogrel or clarithromycin.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Crossover
盲法: None

入排标准

年龄范围: 19 Years 至 55 Years（Adult）
性别: Male
接受健康志愿者: 是

入选标准

•must be healthy volunteer

排除标准

•must not be under 18 years old

研究组 & 干预措施

sibutramine-clopidogrel

Active Comparator

sibutramine-clopidogrel

干预措施: Sibutramine-clopidogrel (Drug)

sibutramine-clarithromycin

Active Comparator

sibutramine-clarithromycin

干预措施: sibutramine-Clarithromycin (Drug)

结局指标

主要结局

effects of clopidogrel and clarithromycin on the disposition of sibutramine

时间窗: one year

the effects of clopidogrel and clarithromycin on the disposition of sibutramine and its two active metabolites M1 and M2 in vivo in relation to CYP2B6\*6 genetic polymorphism have been evaluated in Korean healthy subjects.

次要结局

未报告次要终点

研究者

发起方

Inje University

申办方类型

Other

责任方

Principal Investigator

主要研究者

Jae-Gook Shin

Professor

Inje University

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