NCT00316459已完成1 期
A Randomized, Double-Blind, Placebo and Moxifloxacin (Open-Label) Controlled, 4-Period, Crossover Study of the Effects of Multiple Oral Doses of ERB-041 on Cardiac Repolarization in Healthy Subjects
Wyeth is now a wholly owned subsidiary of Pfizer1 个研究点 分布在 1 个国家目标入组 64 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
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- To assess the effect of ERB-041 after multiple oral doses on cardiac repolarization as assessed by the QTc interval
研究概览
简要总结
To assess the effect of ERB-041 after multiple oral doses on cardiac repolarization as assessed by the QTc interval.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and ECG.
- •Nonsmoker or smoker of fewer than 10 cigarettes (half a pack) per day as determined by history.
排除标准
- •A family history of long QT syndrome and/or cardiac death.
- •Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematological, neurological, or psychiatric disease.
结局指标
主要结局
To assess the effect of ERB-041 after multiple oral doses on cardiac repolarization as assessed by the QTc interval
次要结局
- To characterize pharmacokinetic and pharmacodynamic relationships as it relates to QTc.
研究者
研究点 (1)
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