NCT01189175已完成1 期
Relative Bioavailability of a Single Oral Dose of BI 113823 (50 mg qd) When Administered Alone or in Combination With Multiple Oral Doses of Ketoconazole (200 mg Bid) in Healthy Male Volunteers (an Open Label, Two Periods, Fixed-sequence, Clinical Phase I Study)
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- AUC0-∞(area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) of BI 113823
研究概览
简要总结
The objective of the study is to investigate whether ketoconazole affects plasma exposure of BI 113823
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 50 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
BI 113823
Experimental
single oral dose per subject
干预措施: BI 113823 (Drug)
BI 113823 + Ketokonazole
Experimental
after wash-out 5 days ketokonazole with BI 113823 on day 3
干预措施: BI 113823 + Ketokonazole (Drug)
结局指标
主要结局
AUC0-∞(area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) of BI 113823
时间窗: 2 weeks
Cmax (maximum measured concentration of the analyte in plasma) of BI 113823
时间窗: 2 weeks
次要结局
- MRTpo (mean residence time of the analyte in the body after po administration)(2 weeks)
- t1/2 (terminal half-life of the analyte in plasma)(2 weeks)
- AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)(2 weeks)
- Number of participants with clinically significant changes in physical examination(up to 24 days)
- Number of participants with clinically significant changes in vital signs(up to 24 days)
- CLR,0-24 (renal clearance of the analyte in plasma from the time point 0 until the time point 24)(visit 2, day 1 and visit 4 day 1)
- Number of participants with clinically significant changes in ECG(up to 24 days)
- Number of participants with clinically significant changes in laboratory tests(up to 24 days)
- Assessment of tolerability by the investigator(up to 24 days)
- AUC0-tmax (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to median tmax(2 weeks)
- Occurrence of adverse events(up to 24 days)
- AUCt1-t2 (Area under the concentration time curve of the analyte in plasma over the time interval t1 to t2)(2 weeks)
- tmax (time from dosing to the maximum concentration of the analyte in plasma)(2 weeks)
- λz (terminal rate constant in plasma) t1/2 (terminal half-life of the analyte in plasma(2 weeks)
- CL/F (apparent clearance of the analyte in the plasma after extravascular administration)(2 weeks)
- Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)(2 weeks)
- Ae0-24 (amount of analyte that is eliminated in urine from the time interval 0 to 24)(visit 2, day 1 and visit 4 day 1)
- fe0-24 (fraction of administered drug excreted unchanged in urine from time point 0 to 24(visit 2, day 1 and visit 4 day 1)
研究者
研究点 (1)
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