A PHASE 1, OPEN-LABEL, RANDOMIZED, 2-PERIOD, 2-SEQUENCE, CROSSOVER STUDY TO EVALUATE THE BIOEQUIVALENCE OF BOSUTINIB PEDIATRIC CAPSULE AND THE COMMERCIAL TABLET FORMULATIONS IN HEALTHY PARTICIPANTS UNDER FED CONDITION
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-inf)]
研究概览
简要总结
This study is intended to establish bioequivalence of the bosutinib age-appropriate capsule formulation to the commercial tablet formulation in healthy participants under fed condition. The comparison will be performed using the pharmacokinetic parameters that define the rate and extent of absorption, those are Cmax and AUC. A statistical analysis will be performed comparing these parameters calculated after administration of a single 100 mg dose with the tablet formulation (100 mg x 1) as the Reference treatment and the capsule formulation (100 mg x 1) as the Test treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
盲法说明
Open Label
入排标准
- 年龄范围
- 18 Years 至 54 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Female participants of non childbearing potential and/or male participants must be 18 to 54 years of age, inclusive, at the time of signing the ICD.
- •Capable of giving signed informed consent as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.
排除标准
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, dermatological, or allergic disease.
- •Any condition possibly affecting drug absorption.
研究组 & 干预措施
Bosutinib capsule
Bosutinib pediatric capsule to healthy participants
干预措施: Bosutinib capsule (Drug)
Bosutinib tablet
Bosutinib tablet to healthy participants
干预措施: Bosutinib tablet (Drug)
结局指标
主要结局
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-inf)]
时间窗: 6 days
Area Under the Curve From Time Zero to Extrapolated Infinite Time \[AUC (0-inf)\]
Maximum Observed Plasma Concentration (Cmax)
时间窗: 6 days
Maximum Observed Plasma Concentration (Cmax)
次要结局
- Apparent Oral Clearance (CL/F)(6 days)
- Plasma elimination half-life (t1/2)(6 days)
- Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)(6 days)
- Time to Cmax (Tmax)(6 days)
- Apparent Volume of Distribution (Vz/F)(6 days)