NCT02058277已完成1 期
An Open-Label, Randomized, 2-Period Crossover Study To Evaluate The Effect Of A Single Dose Of Aprepitant, A Moderate CYP3A Inhibitor On Bosutinib Administered Orally To Healthy Subjects
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
- 20
- 试验地点
- 1
- 主要终点
- Area under the Concentration-Time Curve (AUC)
研究概览
简要总结
This is an open label, randomized, single dose, one cohort, two sequence, two period crossover study in healthy subjects. The primary objective of the study is to evaluate the effect of a single oral dose of aprepitant on the pharmacokinetic (PK) profile of a single oral dose of bosutinib in healthy subjects.
研究设计
- 研究类型
- Interventional
- 干预模型
- Crossover
- 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 and/or female subjects with an informed consent document signed and dated by the subject.
排除标准
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease
- •Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of non hormonal contraception as outlined in this protocol .
- •Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half lives (whichever is longer) prior to the first dose of study medication.
研究组 & 干预措施
Healthy volunteers
Other
Healthy volunteers taking a single dose of bosutinib and a single dose of bosutinib plus aprepitant in random order
干预措施: bosutinib or bosutinib + aprepitant (Drug)
结局指标
主要结局
Area under the Concentration-Time Curve (AUC)
时间窗: 96 hours
AUC is a measure of the plasma concentration of the drug over time. It is used to characterize drug absorption.
Maximum Observed Plasma Concentration (Cmax)
时间窗: 96 hours
Cmax is the peak concentration.
次要结局
- Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)(96 hours)
- Time to Reach Maximum Observed Plasma Concentration (Tmax)(96 hours)
- Plasma Decay Half-Life (t1/2)(96 hours)
- Apparent Oral Clearance (CL/F)(96 hours)
- Apparent Volume of Distribution (Vz/F)(96 hours)
研究者
研究点 (1)
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