NCT02975843已完成1 期
Open Label, Uncontrolled, Non-randomized, Single Dose, Scintigraphic Study to Investigate Lung Deposition of Inhaled 99mTc Radiolabelled CHF5993 pMDI in Healthy Volunteers, Asthmatic and COPD Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
- 主要终点
- Intrapulmonary Lung deposition expressed as % of nominal dose
研究概览
简要总结
The purpose of this study is to investigate the lung deposition and distribution pattern of Beclometasone dipropionate/Formoterol Fumarate/Glycopyrronium Bromide using a Gamma-scintigraphic technique after inhalation of a single dose of 99mTc radiolabelled CHF 5993 Administered via pMDI in healthy volunteers, asthmatic and COPD patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 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
CHF5993
Experimental
99mTc Radiolabelled Beclometasone dipropionate/Formoterol Fumarate/Glycopyrronium Bromide administered via pMDI
干预措施: Beclometasone dipropionate/Formoterol Fumarate/Glycopyrronium (Drug)
结局指标
主要结局
Intrapulmonary Lung deposition expressed as % of nominal dose
时间窗: Immediately after dosing
Calculated using the individual Gamma camera images
次要结局
- Extrathoracic deposition(Immediately after dosing)
- Distribution of lung deposition(Immediately after dosing)
- BDP/B17MP, Formoterol, and GB Peak Plasma Concentration (Cmax)(the value of the maximum plasma concentration will be obtained directly from the experimental data without interpolation. Over 24h)
- BDP/B17MP, Formoterol, and GB tmax(time of the maximum plasma concentration will be obtained directly from the experimental data without interpolation. Over 24h)
- Exhaled activity(Immediately after dosing)
- BDP/B17MP, Formoterol, and GB Area under curve (AUC) 0-t(the area under the plasma concentration-time curve from 0 to the last quantifiable concentration. Over 24h)
- BDP/B17MP, Formoterol, and GB Area under curve (AUC) 0-30min(area under the plasma concentration-time curve from 0 to 30 min post-dose)
- BDP/B17MP, Formoterol, and GB area under the curve (AUC) 0-∞(area under the curve extrapolated to infinity over 24h)
- BDP/B17MP, Formoterol, and GB t½(the terminal (apparent elimination) half-life over 24h)
- lung function assessment(Over 24 h post dose)
研究者
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