NCT00380328已完成1 期
An Open-label, Randomized, 2-period Crossover, Drug Interaction Study to Evaluate the Potential Pharmacokinetic Interaction Between Multiple Doses of Ketoconazole and a Single Dose of HKI-272 Administered Orally to Healthy Subjects
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 主要终点
- Pharmacokinetics; safety and tolerability
研究概览
简要总结
To investigate a potential pharmacokinetic drug interaction between HKI-272 and ketoconazole when co-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 50 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 12-lead ECG.
排除标准
- 未提供
结局指标
主要结局
Pharmacokinetics; safety and tolerability
次要结局
未报告次要终点
研究者
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