Relative Bioavailability of a Single Oral Dose of 40 mg Afatinib Given Alone and After Multiple Doses of Rifampicin - an Open-label, Two-period, Fixed Sequence Clinical Phase I Trial in Healthy Male Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Area Under Curve From 0 to Infinity Hours (AUC0-∞)
研究概览
简要总结
The objective of the current study is to investigate the effect of the P-gp inducer rifampicin on the pharmacokinetics (PK) of afatinib in healthy male volunteers
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
Rifampicin + Afatinib (Test)
Tablet, Oral administration with 240 mL of water
干预措施: Afatinib (Drug)
Afatinib alone (Reference)
Tablet, Oral administration with 240 mL of water
干预措施: Afatinib (Drug)
Rifampicin + Afatinib (Test)
Tablet, Oral administration with 240 mL of water
干预措施: Rifampicin (Drug)
结局指标
主要结局
Area Under Curve From 0 to Infinity Hours (AUC0-∞)
时间窗: 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post dose
AUC0-∞ represents the area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity.
Area Under Curve From 0 to tz (AUC0-tz)
时间窗: 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post dose
AUC0-tz represents the area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable drug plasma concentration.
Maximum Concentration (Cmax)
时间窗: 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post dose
Cmax represents the maximum concentration of the analyte in plasma.
次要结局
- Time From Dosing to the Maximum Concentration of Afatinib in Plasma (Tmax)(0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post dose)
- Terminal Half-life of Afatinib in Plasma (t1/2)(0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post dose)
- Area Under Curve From 0 to 24 h (AUC0-24)(0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post dose)
- Percentage of the AUCtz-∞ Obtained by Extrapolation (%AUCtz-∞)(0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post dose)
- Mean Residence Time of Afatinib in the Body After Oral Administration (MRTpo)(0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post dose)
- Apparent Clearance of Afatinib in the Plasma After Extravascular Administration (CL/F)(0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post dose)
- Apparent Volume of Distribution During the Terminal Phase lambda_z Following an Extravascular Dose (V_z/F)(0.5, 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 36, 48, 72, 96, 120 hours post dose)