Pharmacokinetics of the Fixed Dose Combination of Tiotropium Plus BI 54903 Versus the Combination of the Monoproducts of Tiotropium and BI 54903 in Healthy Volunteers
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
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
研究概览
研究类型
注册 (实际的)
阶段
- 阶段1
联系人和位置
学习地点
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Ingelheim、德国
- 1298.2.1 Boehringer Ingelheim Investigational Site
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion criteria:
- Healthy males and females according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), clinical laboratory tests.
- Age 21 to 50 years.
Exclusion criteria:
- Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
- Any evidence of a clinically relevant concomitant disease
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- History or evidence of relevant psychiatric disorders or neurological disorders
- History or evidence of relevant autonomic dysfunction (orthostatic hypotension, fainting spells or blackouts)
- Chronic or relevant acute infections
- History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
- Intake of any prescription drugs or over-the-counter (over the counter (OTC)) medication (vitamins, herbal supplements, dietary supplements) with a long half-life (> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
- Participation in another trial with an investigational drug within two months prior to administration or during the trial
- Smoker (more than 10 cigarettes daily)
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:交叉作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:Treatment A: Tiotropium medium dose
Oral inhalation daily for 21 days
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Medium dose of oral inhalation
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实验性的:Treatment A: BI 54903 high dose
Oral inhalation daily for 21 days
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Medium dose of oral inhalation
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实验性的:Treatment B: Tiotropium medium dose
Oral inhalation daily for 21 days
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Medium dose of oral inhalation
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实验性的:Treatment C: BI 54903 high dose
Oral inhalation daily for 21 days
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Medium dose of oral inhalation
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
Area under the concentration time curve of CD 1857 in plasma over a uniform dosing interval τ (AUCτ,ss)
大体时间:on several time points until day 22
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on several time points until day 22
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Maximum concentration of CD 1857 in plasma at steady state (Cmax,ss)
大体时间:on several time points until day 22
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on several time points until day 22
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AUCτ,ss for Tiotropium
大体时间:on several time points until day 22
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on several time points until day 22
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Cmax,ss for Tiotropium
大体时间:on several time points until day 22
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on several time points until day 22
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次要结果测量
结果测量 |
大体时间 |
---|---|
AUCτ,ss for BI 54903
大体时间:on several time points until day 22
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on several time points until day 22
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Cmax,ss for BI 54903
大体时间:on several time points until day 22
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on several time points until day 22
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Ae0-24 (Amount of analyte that is eliminated in urine) for tiotropium
大体时间:on Day 1 and 21
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on Day 1 and 21
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Change in physical examination
大体时间:9 weeks
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9 weeks
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Change in vital signs
大体时间:9 weeks
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9 weeks
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Change in 12-lead electrocardiogram
大体时间:9 weeks
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9 weeks
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Change in clinical laboratory tests
大体时间:9 weeks
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9 weeks
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Occurrence of Adverse Events
大体时间:9 weeks
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9 weeks
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Assessment of tolerability by the investigator
大体时间:9 weeks
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9 weeks
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合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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