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临床试验/NCT00032916
NCT00032916Unknown1 期

Drug Interaction Study With NS2359 and Cocaine in Cocaine Experienced Volunteers

National Institute on Drug Abuse (NIDA)2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2001年6月最近更新:
适应症
相关药物

试验速览

阶段
1 期
入组人数
24
试验地点
2
主要终点
Pharmacokinetic parameter comparison

研究概览

简要总结

The purpose of this study is to conduct a drug interaction study with NS2359 and cocaine in cocaine experienced volunteers.

详细描述

This is a single-center, double-blind, placebo-controlled, randomized, single dose, fixed order, dose escalating inpatient design that will study oral NS2359 in cocaine experienced volunteers.

研究设计

研究类型
Interventional
分配方式
Randomized
主要目的
Treatment
盲法
Double

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Male or Female, 18-45 yrs of age; females of child-bearing potential using appropriate method of birth control; be able to understand the procedure and agrees to participate via informed consent; must be cocaine dependent according to DSM-4 criteria; must be capable of providing written consent; must be able to comply with protocol requirement, CPU rules and regulations; must not be currently seeking treatment for cocaine abuse.

排除标准

  • Incapable of understanding the informed consent process; Additional criteria available during screening at the site.

结局指标

主要结局

Pharmacokinetic parameter comparison

plasma concentration

次要结局

未报告次要终点

研究者

申办方类型
Nih

研究点 (2)

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