jRCT2080224000已完成1 期
Safety, tolerability, pharmacokinetics and pharmacodynamics of multiple rising oral doses of BI 690517 in healthy Japanese male subjects (double-blind, randomised, placebo-controlled within dose groups)
Nippon boehringer ingelheim1 个研究点目标入组 36 人开始时间: 待定最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 干预模型
- Double-blind, randomised, placebo-controlled within dose groups design
- 主要目的
- Other
入排标准
- 年龄范围
- 20age old over 至 50age old under（—）
- 性别
- Male
入选标准
- •Healthy male Japanese subjects, age of 20 to 50 years, body mass index (BMI) of 18.5
- •to 25.0 kg/m2
排除标准
- •Any finding in the medical examination (including BP, PR or ECG) is deviating from
- •normal and judged as clinically relevant by the investigator
- •Repeated measurement of systolic blood pressure outside the range of 100 to 140 mmHg,
- •diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the
- •range of 50 to 90 bpm
结局指标
主要结局
-
safety safety, tolerability, pharmacokinetics
次要结局
未报告次要终点
研究者
研究点 (1)
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