NCT02192294已完成1 期
An Open-label, Randomized, 2-period Crossover Study To Evaluate Absolute Bioavailability Of Bosutinib In 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
- 14
- 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.
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 (of non-childbearing potential).
- •Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
- •Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, accept placement of indwelling catheter for infusion and other study procedures.
排除标准
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies).
- •A positive urine drug screen for cocaine, tetrahydrocannabinol (THC), opiates/opioids, benzodiazepines and amphetamines.
研究组 & 干预措施
Bosutinib
Experimental
干预措施: Oral Bosutinib (Drug)
Bosutinib
Experimental
干预措施: Intravenous infusion of bosutinib (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 serum concentration of the drug over time. It is used to characterize drug absorption.
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)
- Systemic Clearance (CL)(96 hours)
- Maximum Observed Plasma Concentration (Cmax)(96 hours)
- Plasma Decay Half-Life (t1/2)(96 hours)
- Volume of Distribution at Steady State (Vss)(96 hours)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A Drug Interaction Study Between Bosutinib And Aprepitant In Healthy VolunteersHealthyNCT02058277Pfizer20
Unknown
1 期
Pharmacokinetic Assessment of Simultaneous Administration of Clopidogrel and AspirinCoronary Artery DiseaseNCT01388660Ajou University School of Medicine60
已完成
1 期
A Study to Determine the Relative Bioavailability of the MEK Inhibitor, Trametinib, in Subjects With Solid Tumor MalignanciesCancerNCT01725100GlaxoSmithKline80
尚未招募
早期 1 期
An Relative Bioavailability Study of BH006 for Injection in Healthy SubjectsBioavailabilityNCT06427681Zhuhai Beihai Biotech Co., Ltd40
招募中
1 期
Bioequivalence Study of Perindopril Tablets in Healthy Volunteers Under Fasting ConditionsBioequivalenceNCT06213610Pharmtechnology LLC50