A Randomized, Double-Blind, Triple-Dummy, 3-Period Crossover Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a New Formulation of MOA-728 in Subjects on Stable Methadone Maintenance

Bausch Health Americas, Inc.1 个研究点分布在 1 个国家开始时间: 2007年7月1日最近更新: 2019年11月29日

适应症

试验速览

阶段: 1 期
状态: 撤回
发起方: Bausch Health Americas, Inc.
试验地点: 1
主要终点: To characterize the pharmacodynamics of single oral doses of MOA-728 compared to a positive control of MOA-728 administered intravenously in subjects on stable methadone maintenance.

研究概览研究设计入排标准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

To evaluate the effects of single oral doses of MOA-728 compared to a positive control in subjects on methadone therapy.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Crossover
主要目的: Treatment
盲法: Double

入排标准

年龄范围: 18 Years 至 65 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 是

入选标准

•Healthy men or women, aged 18 to 65 years.
•History of methadone treatment for at least 1 month, at a dose >=30 and <=140 mg/day.

排除标准

•History or active presence of clinically important medical disease.
•Allergy to opioids.

结局指标

主要结局

To characterize the pharmacodynamics of single oral doses of MOA-728 compared to a positive control of MOA-728 administered intravenously in subjects on stable methadone maintenance.

次要结局

未报告次要终点

研究者

发起方

Bausch Health Americas, Inc.

申办方类型

Industry

研究点 (1)

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