Comparison of Tiotropium Pharmacokinetics After Inhalation From Tiotropium Easyhaler® Product Variants and After Spiriva® Capsules Administered Via HandiHaler®; Study in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Area under the concentration-time curve from time zero to 72 hours (AUC72 hours)
研究概览
简要总结
Absorption of inhaled tiotropium is compared between five Tiotropium Easyhaler product variants and Spiriva capsules inhaled via HandiHaler without charcoal. Absorption of tiotropium is compared between one Easyhaler product variant administered with and without charcoal.
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
Spiriva HandiHaler
干预措施: Tiotropium Bromide Monohydrate (Drug)
Tiotropium Easyhaler Product variant D
干预措施: Tiotropium Bromide Monohydrate (Drug)
Tiotropium Easyhaler Product variant H
干预措施: Tiotropium Bromide Monohydrate (Drug)
Tiotropium Easyhaler Product variant E
干预措施: Tiotropium Bromide Monohydrate (Drug)
Tiotropium Easyhaler Product variant F
干预措施: Tiotropium Bromide Monohydrate (Drug)
Tiotropium Easyhaler Product variant G
干预措施: Tiotropium Bromide Monohydrate (Drug)
Tiotropium Easyhaler Product variant F administered with oral activated charcoal
干预措施: Tiotropium Bromide Monohydrate (Drug)
Tiotropium Easyhaler Product variant F administered with oral activated charcoal
干预措施: Tiotropium Easyhaler with oral activated charcoal (Drug)
结局指标
主要结局
Area under the concentration-time curve from time zero to 72 hours (AUC72 hours)
时间窗: 0-72 hours 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 30 minutes (AUC30 minutes)
时间窗: 0-30 minutes after dosing
次要结局
- Time to reach peak concentration in plasma (tmax)(between 0-72 hours after dosing)