NCT01398111已完成1 期
Open-label, Randomized, Single-dose, Placebo-controlled, 4-way Crossover Study to Investigate the Pharmacokinetic Interaction of Glycopyrrolate and Formoterol in Healthy Subjects.
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
- 44
- 试验地点
- 1
- 主要终点
- Pharmacokinetics: formoterol and glyco AUC0-t
研究概览
简要总结
This study will be carried out in healthy volunteers with the primary objective to evaluate the pharmacokinetic interaction between Glyco and Formoterol administered using a pressurised metered dose inhaler (pMDI).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females healthy volunteers aged 18-65 years will be included in the study.
排除标准
- 未提供
研究组 & 干预措施
Treatment R2
Active Comparator
干预措施: Formoterol (Drug)
Treatment R1
Active Comparator
干预措施: Glycopyrrolate (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Treatment T
Experimental
干预措施: Glycopyrrolate + Formoterol (Drug)
结局指标
主要结局
Pharmacokinetics: formoterol and glyco AUC0-t
时间窗: from pre-dose to 32 hours after administration
Area under the plasma concentration curve observed from administration up to the last measurable concentration.
Pharmacokinetics: formoterol and glyco Cmax
时间窗: from pre-dose to 32 hours after administration
Maximum plasma concentration
次要结局
- Lung function(from pre-dose to 1 hour after administration)
- Vital signs(from pre-dose to 24 hours after administration)
- ECG(from pre-dose to 24 hours after administration)
- Additional pharmacokinetic variables(from pre-dose to 32 hours post dose)
- Serum potassium(From pre-dose to 24 hours after administration)
- Plasma glucose(from pre-dose to 24 hours after administration)
研究者
研究点 (1)
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