Relative Bioavailability of a Single Oral Dose of 40 mg Afatinib Given Alone Compared to Concomitant and Timed Administration of Multiple Oral Doses of Ritonavir - an Open-label, Randomised, Three-way Crossover Trial in Healthy Male Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Maximum Concentration (Cmax)
研究概览
简要总结
To study the effect of the P-glycoprotein inhibitor ritonavir on the pharmacokinetics (PK) of afatinib depending on the timepoint of ritonavir administration
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
treatment A
1 tablet afatinib single dose
干预措施: afatinib (Drug)
treatment B
2 x 2 tablets ritonavir for 3 days + 1 tablet afatinib on the second treatment day
干预措施: ritonavir + afatinib (Drug)
treatment C
2 x 2 tablets ritonavir for 3 days + 1 tablet afatinib on the second treatment day
干预措施: ritonavir + afatinib (Drug)
结局指标
主要结局
Maximum Concentration (Cmax)
时间窗: 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post
Cmax represents the maximum concentration of the analyte in plasma.
Area Under Curve From 0 to tz (AUC0-tz)
时间窗: 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post
AUC0-tz represents the area under the concentration curve of the analyte in plasma from 0 to the time of the last quantifiable plasma contentration of the analyte.
Area Under Curve From 0 to ∞ Hours (AUC0-∞)
时间窗: 0, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post
AUC0-∞ represents the area under the concentration curve of the analyte in plasma from 0 extrapolated to infinity.
次要结局
未报告次要终点