jRCT2031200227已完成不适用
An open-label, randomized, two treatment epochs complete cross-over study to assess pharmacokinetics of indacaterol acetate, glycopyrronium bromide and mometasone furoate in Japanese and Caucasian healthy subjects following multiple inhaled doses of QVM149 via the Concept1 device
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 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
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Crossover Assignment
- 主要目的
- Other
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 20age old over 至 45age old under（—）
- 性别
- Male
入选标准
- •Healthy male subjects 20 to 45 (inclusive) years of age and in good health as determined by past medical history, physical examination, vital signs, ECG, and laboratory tests at screening and first baseline.
- •Japanese subjects are to be of first generation ethnic origin. Caucasian subjects are to be of first generation Caucasian origin.
排除标准
- •Use of other investigational drugs at screening, or within 5 half-lives of enrollment, or within four (4) months, whichever is longer; or longer if required by local regulations.
- •Inability to use the Concept1 device at screening.
结局指标
主要结局
-
Pharmacokinetics
次要结局
未报告次要终点
研究者
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