NCT01291732已完成1 期
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses (12.5 mg, 50 mg, 200 mg) of BI 135585 XX (Tablet) in Chinese and Japanese Healthy Male Volunteers (Randomised, Double-blind,Placebo-controlled Within Dose Groups)
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Occurrence of Adverse events
研究概览
简要总结
The Aim of the study is to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics in Asian healthy males administered a single dose of BI 135585.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 20 Years 至 45 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 135585 XX
Experimental
single dose of BI 135585
干预措施: BI 135585 XX (Drug)
matching placebo
Placebo Comparator
single dose of matching placebo
干预措施: Matching placebo (Drug)
结局指标
主要结局
Occurrence of Adverse events
时间窗: up to 21 days
Changes in 12-lead ECG (electrocardiogram)
时间窗: up to 21 days
Changes in Vital signs (blood pressure (BP), pulse rate (PR), respiratory rate(RR))
时间窗: up to 21 days
Changes in Clinical laboratory tests (haematology, clinical chemistry and urinalysis)
时间窗: up to 21 days
次要结局
- Tmax (maximum measured concentration of the analyte in plasma)(10 days)
- AUC0-8 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)(10 days)
- Cmax (maximum measured concentration of the analyte in plasma)(10 days)
研究者
研究点 (1)
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