NCT00757809已完成1 期
A Blinded, Randomized, Multiple-Dose, Parallel Group Study to Characterize the Occurrence of Mild to Moderate Diarrhea After Administration of Neratinib Either 240-mg Once Daily or 120-mg Twice Daily for 14 Days to Healthy Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 50
- 主要终点
- Occurence of diarrhea
研究概览
简要总结
Study to investigate the occurence of diarrhea after either once daily or twice daily dosing for 14 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female (non-child bearing potential) subjects
- •Ages 18-50.
排除标准
- 未提供
研究组 & 干预措施
QD
Experimental
Once daily
干预措施: neratinib (Drug)
BID
Experimental
Twice daily
干预措施: neratinib (Drug)
结局指标
主要结局
Occurence of diarrhea
时间窗: 14 days
次要结局
未报告次要终点
研究者
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