临床试验/NCT00818155

NCT00818155已完成1 期

Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Desvenlafaxine Succinate Sustained Release Administered Orally to Healthy Chinese Subjects.

Wyeth is now a wholly owned subsidiary of Pfizer0 个研究点目标入组 36 人开始时间: 2009年1月最近更新: 2013年1月29日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方
入组人数: 36
主要终点: Safety and tolerability as evaluated from reported adverse events, scheduled physical examinations, vital sign measurements, cardiac rhythm monitoring, 12 lead ECG and clinical laboratory results.

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

The main purpose of this study is to evaluate the safety and tolerability of desvenlafaxine succinate SR in healthy male and female Chinese subjects. The amount of drug in the body and the effects of the drug will also be evaluated.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Single Group
主要目的: Treatment
盲法: Double (Participant, Investigator)

入排标准

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

入选标准

未提供

排除标准

未提供

研究组 & 干预措施

desvenlafaxine succinate SR

Experimental

desvenlafaxine succinate SR

干预措施: desvenlafaxine succinate SR (Drug)

Placebo

Placebo Comparator

干预措施: Placebo (Other)

结局指标

主要结局

Safety and tolerability as evaluated from reported adverse events, scheduled physical examinations, vital sign measurements, cardiac rhythm monitoring, 12 lead ECG and clinical laboratory results.

时间窗: 2 months

次要结局

Pharmacokinetics as evaluated from blood and urine concentrations of desvenlafaxine(2 months)

研究者

发起方

Wyeth is now a wholly owned subsidiary of Pfizer

申办方类型

Industry

责任方

Sponsor

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