A Pharmacokinetic Feasibility Study on Ultibro Breezhaler, an Indacaterol-glycopyrronium Inhalation Powder Capsule, in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Peak indacaterol concentration in plasma (Cmax)
研究概览
简要总结
The objective of this study is to assess pharmacokinetics (PK) of indacaterol and glycopyrronium, and methodology and practical arrangements for future studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 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
Part 1 Ultibro Breezhaler 2 capsules, Batch A
干预措施: Indacaterol maleate and glycopyrronium bromide (Drug)
Part 1 Ultibro Breezhaler 2 capsules with charcoal, Batch A
干预措施: Indacaterol maleate and glycopyrronium bromide (Drug)
Part 1 Ultibro Breezhaler 2 capsules with charcoal, Batch A
干预措施: Ultibro Breezhaler with oral charcoal (Drug)
Part 1 Ultibro Breezhaler 1 capsule, Batch A
干预措施: Indacaterol maleate and glycopyrronium bromide (Drug)
Part 2 Ultibro Breezhaler 2 capsules, Batch A
干预措施: Indacaterol maleate and glycopyrronium bromide (Drug)
Part 2 Ultibro Breezhaler 2 capsules, Batch B
干预措施: Indacaterol maleate and glycopyrronium bromide (Drug)
结局指标
主要结局
Peak indacaterol concentration in plasma (Cmax)
时间窗: between 0-72 hours after dosing
Peak glycopyrronium concentration in plasma (Cmax)
时间窗: between 0-72 hours after dosing
Indacaterol area under the concentration-time curve from time zero to 30 minutes (AUC30min)
时间窗: 0-30 minutes after dosing
Glycopyrronium area under the concentration-time curve from time zero to 30 minutes (AUC30min)
时间窗: 0-30 minutes after dosing
Indacaterol area under the concentration-time curve from time zero to 72 hours (AUC72h)
时间窗: 0-72 hours after dosing
Glycopyrronium area under the concentration-time curve from time zero to 72 hours (AUC72h)
时间窗: 0-72 hours after dosing
次要结局
- Indacaterol area under the concentration-time curve from time zero to the last sample with a quantifiable concentration (AUCt)(0-18 days after dosing)
- Glycopyrronium area under the concentration-time curve from time zero to the last sample with a quantifiable concentration (AUCt)(0-18 days after dosing)
- Indacaterol area under the concentration-time curve from time zero to infinity (AUCinf)(0-18 days after dosing)
- Glycopyrronium area under the concentration-time curve from time zero to infinity (AUCinf)(0-18 days after dosing)
- Indacaterol terminal elimination half-life (t1/2)(0-18 days after dosing)
- Time to reach peak indacaterol concentration in plasma(between 0-72 hours after dosing)
- Time to reach peak glycopyrronium concentration in plasma(between 0-72 hours after dosing)
- Number of adverse events as event counts and subjects counts(throughout the study, average 9-12 weeks)
- Glycopyrronium terminal elimination half-life (t1/2)(0-18 days after dosing)