临床试验/NCT01648270

NCT01648270已完成不适用

Influence of Cyclosporine on Buprenorphine Disposition

Washington University School of Medicine1 个研究点分布在 1 个国家目标入组 25 人开始时间: 2012年4月最近更新: 2020年1月22日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方: Washington University School of Medicine
入组人数: 25
试验地点: 1
主要终点: Buprenorphine Plasma Cmax

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

The determine the effect of cyclosporine on buprenorphine disposition

详细描述

Subjects studied on four occasions:

Intravenous buprenorphine
Sublingual buprenorphine
Cyclosporine, then intravenous buprenorphine. Subjects then take oral cyclosporine twice daily, until
Sublingual buprenorphine; continue oral cyclosporine twice daily for 5 days

研究设计

研究类型: Interventional
干预模型: Sequential
主要目的: Other
盲法: None

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

•18-50 yr old
•Good general health with no remarkable medical conditions
•BMI < 33
•Provide informed consent

排除标准

•Known history of liver or kidney disease
•Use of prescription or non prescription medications, herbals or foods known to be metabolized by or affecting CYP3A
•Females who are pregnant or nursing
•Known history of drug or alcohol addiction (prior or present addiction or treatment for addiction)
•Direct physical access to and routine handling of addicting drugs in the regular course of duty (a routine exclusion from studies of drugs with addiction potential)

研究组 & 干预措施

Study Arm

Experimental

Subjects will be studied on four occasions. Sessions and drugs are:

Intravenous buprenorphine
Sublingual buprenorphine
Cyclosporine plus intravenous buprenorphine
Cyclosporine plus sublingual buprenorphine

干预措施: buprenorphine (Drug)

结局指标

主要结局

Buprenorphine Plasma Cmax

时间窗: 96 hours

次要结局

未报告次要终点

研究者

发起方

Washington University School of Medicine

申办方类型

Other

责任方

Sponsor

研究点 (1)

Loading locations...

相似试验

已完成

2 期

Buprenorphine Pharmacology Related to Addiction Treatment - 21Opioid-Related Disorders

NCT00000239National Institute on Drug Abuse (NIDA)

已完成

1 期

Buprenorphine Accumulation and Description of Its Metabolites During Co-Medication of Buprenorphine Transdermal System (BTDS) and KetoconazoleHealthy

NCT01259115Purdue Pharma LP20

已完成

2 期

Cocaine Use Reduction With BuprenorphineCocaine Dependence

NCT01402492University of California, Los Angeles302

Unknown

1 期

Pharmacokinetics and Pharmacodynamics of Buprenorphine in Healthy VolunteersHealthy Volunteers

NCT00347815Danish University of Pharmaceutical Sciences24

已完成

不适用

Effect of Buprenorphine and Bupropion in the reduction of hashish cravingCannabis Dependency.Mental and behavioural disorders due to use of cannabinoids

IRCT2016040525160N3Vice chancellor for research, Shiraz University of Medical Sciences40