NCT02041273已完成1 期
A Phase 1, Open-label 6 Sequence 3 Period Crossover Study of Palbociclib (PD- 0332991) in Healthy Volunteers to Estimate the Relative Bioavailability of Palbociclib Formulations
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
- Pfizer
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Maximum Observed Plasma Concentration (Cmax)
研究概览
简要总结
A relative bioavailability study of commercial palbociclib free base hard capsules to the isethionate salt palbociclib capsules ( used in Phase 1 and 2 studies) under different fasting conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male subjects and/or female subjects of non-childbearing potential between the ages of 18 and 55 years.
- •Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
排除标准
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
- •Any condition possibly affecting drug absorption.
研究组 & 干预措施
Palbociclib given to healthy volunteers
Experimental
干预措施: palbociclib commercial free base capsule (Drug)
Palbociclib given to healthy volunteers
Experimental
干预措施: palbociclib isethionate (phase 1 and 2 studies) (Drug)
结局指标
主要结局
Maximum Observed Plasma Concentration (Cmax)
时间窗: 7 days
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]
时间窗: 7 days
AUC (0 - 8)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8). It is obtained from AUC (0 - t) plus AUC (t - 8).
次要结局
- Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)(7 days)
- Apparent Oral Clearance (CL/F)(7 days)
- Plasma Decay Half-Life (t1/2)(7 days)
- Apparent Volume of Distribution (Vz/F)(7 days)
研究者
研究点 (1)
Loading locations...
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