Pharmacokinetics, Safety and Tolerability of Doses of BI 1015550 in Healthy Chinese Male and Female Subjects (Open-label, Parallel Group Design)
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 BI 1015550 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
研究概览
简要总结
The main objectives of this trial are to investigate pharmacokinetics, safety and tolerability of BI 1015550 in Chinese healthy male and female subjects following administration of single doses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 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 1015550 9 mg
A single film-coated tablet of 9 milligram BI 1015550 taken orally after an overnight fast of at least 10 hours.
干预措施: BI 1015550 (Drug)
BI 1015550 18 mg
A single film-coated tablet of 18 milligram BI 1015550 taken orally after an overnight fast of at least 10 hours.
干预措施: BI 1015550 (Drug)
结局指标
主要结局
Area Under the Concentration-time Curve of BI 1015550 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-∞)
时间窗: Within 3 hours before and 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 and 144 hours following drug administration.
Area under the concentration-time curve of BI 1015550 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞).
Maximum Measured Concentration of BI 1015550 in Plasma (Cmax)
时间窗: Within 3 hours before and 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 and 144 hours following drug administration.
Maximum measured concentration of BI 1015550 in plasma (Cmax).
次要结局
- Number of Subjects With Any Treatment-emergent Adverse Event (AE)(Up to 7 days.)