An Open Label, Randomised, Two-way Crossover Phase I Study to Assess Safety, Tolerability and Pharmacokinetics of the Fixed Dose Combination of Tiotropium Plus BI 54903 Via Respimat® B Versus the Combination of the Monoproducts of Tiotropium Via Respimat® A and BI 54903 Via Respimat® B in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Maximum concentration of CD 1857 in plasma at steady state (Cmax,ss)
研究概览
简要总结
The primary objective is to compare the systemic exposure to tiotropium and CD 1857 after treatment with the fixed dose combination (fixed dose combination (FDC), Treatment A) of tiotropium plus BI 54903 (ethanolic solution for inhalation (EIS), Respimat (RMT) B) with the systemic exposure following inhalation of the free combination (Treatment B) of tiotropium (aqueous solution for inhalation (AIS), RMT A) plus BI 54903 (EIS, RMT B), when administered once-daily over 21 days via Respimat(R) (RMT).
The secondary objectives are:
to compare the systemic exposure to tiotropium and CD 1857 after single dose administration of FDC and of the free combination of tiotropium/BI 54903 to compare the systemic exposure to BI 54903 after a single dose and at steady state after multiple doses of the FDC and of the free combination of tiotropium/BI 54903 to compare the safety and tolerability of tiotropium and BI 54903 when administered as FDC and as free dose combination, respectively
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 50 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
Treatment A: Tiotropium medium dose
Oral inhalation daily for 21 days
干预措施: Tiotropium (Drug)
Treatment A: BI 54903 high dose
Oral inhalation daily for 21 days
干预措施: BI 54903 (Drug)
Treatment B: Tiotropium medium dose
Oral inhalation daily for 21 days
干预措施: Tiotropium (Drug)
Treatment C: BI 54903 high dose
Oral inhalation daily for 21 days
干预措施: BI 54903 (Drug)
结局指标
主要结局
Maximum concentration of CD 1857 in plasma at steady state (Cmax,ss)
时间窗: on several time points until day 22
Cmax,ss for Tiotropium
时间窗: on several time points until day 22
Area under the concentration time curve of CD 1857 in plasma over a uniform dosing interval τ (AUCτ,ss)
时间窗: on several time points until day 22
AUCτ,ss for Tiotropium
时间窗: on several time points until day 22
次要结局
- AUCτ,ss for BI 54903(on several time points until day 22)
- Change in physical examination(9 weeks)
- Change in vital signs(9 weeks)
- Change in 12-lead electrocardiogram(9 weeks)
- Change in clinical laboratory tests(9 weeks)
- Occurrence of Adverse Events(9 weeks)
- Assessment of tolerability by the investigator(9 weeks)
- Cmax,ss for BI 54903(on several time points until day 22)
- Ae0-24 (Amount of analyte that is eliminated in urine) for tiotropium(on Day 1 and 21)