Pharmacokinetic Study to Compare Tiotropium Easyhaler® Product Variants and Spiriva® 18 µg Capsules Administered Via HandiHaler® in Healthy Volunteers.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Area under the concentration-time curve from time zero to 30 minutes (AUC30 minutes)
研究概览
简要总结
This is a pivotal study to investigate absorption of inhaled tiotropium from 2 Tiotropium Easyhaler product variants and Spiriva capsules inhaled via HandiHaler.
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
盲法说明
Bioanalytical laboratory will be blinded with regard to the sequence of the product administration
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
Tiotropium Easyhaler 10 microg/dose, Product variant J
Each subject will receive a single dose of 2 inhaled doses from Tiotropium Easyhaler Product variant J in one of the three periods (cross-over). The total dose is 20 micrograms of tiotropium (delivered dose) as Tiotropium Bromide Monohydrate.
干预措施: Tiotropium Bromide Monohydrate (Drug)
Tiotropium Easyhaler 10 microg/dose, Product variant K
Each subject will receive a single dose of 2 inhaled doses from Tiotropium Easyhaler Product variant K in one of the three periods (cross-over). The total dose is 20 micrograms of tiotropium (delivered dose) as Tiotropium Bromide Monohydrate.
干预措施: Tiotropium Bromide Monohydrate (Drug)
Spiriva HandiHaler 18 microg/capsule
Each subject will receive a single dose of 2 inhaled Spiriva capsules via HandiHaler device in one of the three periods (cross-over). The total dose is 20 micrograms of tiotropium (delivered dose) as Tiotropium Bromide Monohydrate.
干预措施: Tiotropium Bromide Monohydrate (Drug)
结局指标
主要结局
Area under the concentration-time curve from time zero to 30 minutes (AUC30 minutes)
时间窗: between 0-30 minutes after dosing
Peak tiotropium concentration in plasma (Cmax)
时间窗: between 0-72 hours after dosing
Area under the concentration-time curve from time zero to 72 hours (AUC72 hours)
时间窗: between 0-72 hours after dosing
次要结局
- Time to reach peak concentration in plasma (tmax)(between 0-72 hours after dosing)