A Phase 1, Open-Label, Randomized, Single-Dose, 2-Cohort, 2-Way Crossover Bioequivalence Study To Compare The Bosutinib Clinical Tablet And Clinical Capsule And To Investigate Food Effect On Bosutinib Commercial Formulation in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Plasma Cmax for bosutinib.
研究概览
简要总结
The purpose of this study is to demonstrate the bioequivalence of the clinical tablet formulation (100 mg x 5) to the clinical capsule formulation (100 mg x 5) in healthy subjects under fed condition (Cohort 1) and to investigate the effect of a high-fat meal on the pharmacokinetics of bosutinib after administration of the proposed commercial tablet formulation (100 mg x 4) in healthy subjects (Cohort 2).
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
- 21 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and/or female of non childbearing potential subjects between the ages of 21 and 55 years, inclusive.
- •Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 Lead ECG or clinical laboratory tests.
排除标准
- •Pregnant or nursing women or women of childbearing potential.
研究组 & 干预措施
Cohort 1
干预措施: Bosutinib (Drug)
Cohort 2
干预措施: Bosutinib (Drug)
结局指标
主要结局
Plasma Cmax for bosutinib.
时间窗: 96 hr post dose in each period
AUCt for bosutinib.
时间窗: 96 hr post dose in each period
Plasma AUCinf for bosutinib.
时间窗: 96 hr post dose in each period
AUClast for bosutinib.
时间窗: 96 hr post dose in each period
Tmax for bosutinib.
时间窗: 96 hr post dose in each period
t½ for bosutinib.
时间窗: 96 hr post dose in each period
次要结局
未报告次要终点