NCT01707940已完成1 期
Relative Bioavailability of a Single Oral Dose of BI 144807 (Oral Solution) When Administered Alone or in Combination With Multiple Oral Doses of Ketoconazole (200 mg Tablet) in Healthy Male Subjects (an Open-label, Two-period, Fixed-sequence Trial)
适应症
干预措施
相关药物
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
- Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity
研究概览
简要总结
This trial investigates the influence of oral ketoconazole on the pharmacokinetics and safety of BI 144807.
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 144807
Experimental
subjects receive an oral single dose of BI 144807
干预措施: BI 144807 (Drug)
BI 144807 plus Ketoconazole
Experimental
subjects receive bid ketoconazole plus an oral single dose of BI 144807
干预措施: Ketoconazole (Drug)
BI 144807 plus Ketoconazole
Experimental
subjects receive bid ketoconazole plus an oral single dose of BI 144807
干预措施: BI 144807 (Drug)
结局指标
主要结局
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity
时间窗: 0 to 48 hours after administration
Maximum measured concentration of the analyte in plasma
时间窗: 0 to 48 hours after administration
次要结局
- Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point(0 to 48 hours after administration)
研究者
研究点 (1)
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