NCT00934674已完成1 期
A Single Dose Bioequivalence Study Comparing the Commercial Tablet Formulation to the Clinical Tablet of Bosutinib in Healthy Subjects
Wyeth is now a wholly owned subsidiary of Pfizer0 个研究点目标入组 30 人开始时间: 2009年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 主要终点
- Pharmacokinetics as measured by Cmax, AUC, tmax, and t1/2
研究概览
简要总结
This study is comparing 2 formulations of bosutinib in healthy subjects.
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
- •Men or women of non-childbearing potential, age 18 to 50 years.
排除标准
- •Any significant cardiovascular, renal, hepatic, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
研究组 & 干预措施
1
Experimental
Commercial Tablet manufactured by Excella
干预措施: SKI-606 (Bosutinib) (Drug)
2
Experimental
Clinical Tablet manufactured by Wyeth Montreal
干预措施: SKI-606 (Bosutinib) (Drug)
结局指标
主要结局
Pharmacokinetics as measured by Cmax, AUC, tmax, and t1/2
时间窗: 2 weeks
次要结局
未报告次要终点
研究者
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