A Phase 1, Open-Label 3 Sequence 3 Period Crossover Study Of Palbociclib (PD-0332991) In Healthy Volunteers To Establish The Bioequivalence Of The Phase 1/2 And Phase 3 Formulation To Palbociclib ICH Formulation Under Fasted Conditions
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]
研究概览
简要总结
This study is intended to establish the equivalence of 2 formulations to the intended final market product. The formulations to compare are the capsule given to patients in the phase I and II studies and the capsule that is being administered to the patients in the phase III trials. Both capsules will be compared to the intended final market capsule. The comparison will be performed looking at 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 a single 125 mg dose of the 3 capsules identifying like that if there are significant differences between these 3 formulations.
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
干预措施: palbociclib capsule: phase 1 and 2 studies (Drug)
Palbociclib given to Healthy Volunteers
干预措施: Palbociclib capsule: phase 3 studies (Drug)
Palbociclib given to Healthy Volunteers
干预措施: Palbociclib capsule: ICH (Drug)
结局指标
主要结局
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).
Maximum Observed Plasma Concentration (Cmax)
时间窗: 7 days
次要结局
- Apparent Oral Clearance (CL/F)(7 days)
- Plasma Decay Half-Life (t1/2)(7 days)
- Apparent Volume of Distribution (Vz/F)(7 days)
- Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)(7 days)
- Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)](7 days)
- Area Under the Curve From Time Zero to 72 hrs [AUC (0-72)](3 days)