NCT00329186已完成3 期
A Randomized, Open-Label, Two-Period, Parallel Group, Crossover Study to Evaluate the Pharmacokinetics of Venlafaxine Extended-Release and DVS SR in Healthy Subjects Who Are Extensive or Poor Cytochrome P450 2D6 Substrate Metabolizers
Wyeth is now a wholly owned subsidiary of Pfizer1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2006年5月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- The primary objective is to determine if the relative difference in PK between EMs and PMs is the same with desvenlafaxine SR and venlafaxine ER when a single dose is administered.
研究概览
简要总结
The purpose of this study is to determine if the relative difference in PK between extensive metabolizers (EMs) and poor metabolizers (PMs) is the same with desvenlafaxine SR and venlafaxine ER when a single dose is administered.
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
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy men and women between 18 to 55 years of age
- •Healthy as determined by the investigator on the basis of medical history and physical examination, laboratory test results, vital signs, and no clinically significant abnormalities on 12-lead electrocardiogram (ECG)
- •History of nonsmoker for at least 1 year
排除标准
- •Presence or history of any disorder or significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, any severe conditions of the ears, eyes or throat (such as glaucoma or increased intraocular pressure), or psychiatric disease that may prevent the completion of the study
- •Known or suspected alcohol abuse or consumption of more than 2 standard units per day within past 6 months or known or suspected abuse of prohibited drugs or other substances
- •Use of any over-the-counter, prescription, hormonal therapy or investigational medications within 30 days of study day -1 until the end of the study
结局指标
主要结局
The primary objective is to determine if the relative difference in PK between EMs and PMs is the same with desvenlafaxine SR and venlafaxine ER when a single dose is administered.
次要结局
未报告次要终点
研究者
研究点 (1)
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