NCT02315131终止1 期
A 2-Stage, Single-Dose Study in Healthy Volunteers and COPD Patients With an Open Label Ipratropium Bromide Reference to Evaluate the Efficacy, Pharmacokinetics, and Safety Profile of Inhaled TV46017
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 53
- 试验地点
- 7
- 主要终点
- FEV1 AUC0-12h
研究概览
简要总结
The primary objective of the study is to characterize the safety profile and duration of bronchodilation of a single dose of inhaled TV46017
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older 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
TV46017- Healthy Volunteers
Experimental
Stage 1 includes a single-dose treatment period
干预措施: TV46017 (Drug)
Placebo - Healthy Volunteers
Placebo Comparator
Some healthy subjects will be randomized to receive placebo.
干预措施: Placebo (Drug)
TV46017 15 μg- COPD
Experimental
Stage 2 includes two 24 hour treatment periods with approximately 7 days of washout in between each treatment period; and open label ipratropium bromide pressurized metered-dose inhaler hydrofluoroalkane (HFA) will be administered
干预措施: TV46017 (Drug)
TV46017 60 μg- COPD
Experimental
Stage 2
干预措施: TV46017 (Drug)
TV46017 120 μg- COPD
Experimental
Stage 2
干预措施: TV46017 (Drug)
TV46017 240 μg- COPD
Experimental
Stage 2
干预措施: TV46017 (Drug)
结局指标
主要结局
FEV1 AUC0-12h
时间窗: Baseline, 12 hours
baseline adjusted forced expiratory volume in 1 second area under the curve over 12 hours
次要结局
- FEV1(Baseline, 12 hours)
- Percentage of Participants with Adverse Events(28 Days)
研究者
研究点 (7)
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