Relative Bioavailability of Single Oral Dose of BI 113608 When Administered Alone or in Combination With Multiple Oral Doses of Ketoconazole or Voriconazole in Healthy Male Subjects (an Open-label, Randomised, Three-period Cross-over Trial)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Maximum Measured Concentration of BI 113608 in Plasma (Cmax)
研究概览
简要总结
The primary objective of this trial is to investigate the relative bioavailability of a single oral dose of BI 113608 without and with ketoconazole and voriconazole at steady state. The assessment of safety and tolerability of BI 113608 administered alone and upon co-administration will be an additional objective of this trial.
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 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
Period 3: BI 113608+Voriconazole
tablets with 240 ml water
干预措施: Voriconazole (Drug)
Period 3: BI 113608+Voriconazole
tablets with 240 ml water
干预措施: BI 113608 (Drug)
Period 2: BI 113608+Ketoconazole
tablets with 240 ml water
干预措施: BI 113608 (Drug)
Period 2: BI 113608+Ketoconazole
tablets with 240 ml water
干预措施: Ketoconazole (Drug)
Period 1: BI 113608
tablets with 240 ml water
干预措施: BI 113608 (Drug)
结局指标
主要结局
Maximum Measured Concentration of BI 113608 in Plasma (Cmax)
时间窗: 1 hour before drug administration and 0:25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24, 34, 48 and 72 hours after drug administration.
This outcome measure presents the maximum measured concentration of BI 113608 in plasma. The parameter dispersion type (standard deviation) is actually intra individual geometric coefficient of variation (intraindividual gCV). Statistical analysis 1: The ratio (Other) is calculated as BI + K (T1): BI (R) \[%\]. Statistical analysis 2: The ratio (Other) is calculated as BI + V (T2): BI (R) \[%\].
Area Under the Concentration-time Curve of BI 113608 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz)
时间窗: 1 hour before drug administration and 0:25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24, 34, 48 and 72 hours after drug administration.
This outcome measure presents the area under the concentration-time curve of BI 113608 in plasma over the time interval from 0 to the last quantifiable data point. The parameter dispersion type (standard deviation) is actually intra individual geometric coefficient of variation (intraindividual gCV). Statistical analysis 1: The ratio (Other) is calculated as BI+K (T1): BI (R) \[%\]. Statistical analysis 2: The ratio (Other) is calculated as BI + V (T2): BI (R) \[%\].
次要结局
- Area Under the Concentration-time Curve of BI 113608 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)(1 hour before drug administration and 0:25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24, 34, 48 and 72 hours after drug administration.)
- Terminal Half-life of BI 113608 in Plasma (t1/2)(1 hour before drug administration and 0:25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24, 34, 48 and 72 hours after drug administration.)
- Time From Dosing to Maximum Measured Concentration of BI 113608 in Plasma (Tmax)(1 hour before drug administration and 0:25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 14, 24, 34, 48 and 72 hours after drug administration.)