NCT02040597已完成1 期
Open-label, Non-randomized, Parallel-group Study to Investigate the Pharmacokinetics, Safety and Tolerability of a Single Dose of CHF 5993 pMDI in Subjects With Mild, Moderate and Severe Renal Impairment in Comparison With Matched Healthy Control Subjects.
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
- 42
- 试验地点
- 2
- 主要终点
- Glycopyrrolate area under the curve (AUC)
研究概览
简要总结
The study is performed to characterize the pharmacokinetics of glycopyrrolate bromide after single administration of CHF 5993 pressurised Metered Dose Inhaler (pMDI) in subjects with different level of renal impairment in comparison with matching healthy volunteers. Moreover, the safety and tolerability of the study drug will be also evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers and
- •Subjects with mild, moderate and severe renal impairment
排除标准
- •pregnant or lactating women
- •positive HIV and hepatitis serology
- •history of drug abuse
- •history of hypersensitivity to the products used in the trial
- •respiratory disease such as asthma and COPD
- •clinically relevant concomitant disease that may introduce a risk for the subjects'safety
- •presence of kidney stones
研究组 & 干预措施
CHF5993 pMDI
Experimental
CHF 5993 pMDI (Beclometasone/Formoterol/Glycopyrrolate 100/6/25 mcg) 4 inhalations
干预措施: Beclometasone/Formoterol/Glycopyrrolate (Drug)
结局指标
主要结局
Glycopyrrolate area under the curve (AUC)
时间窗: over 72 h after single administration
AUC until the last quantifiable concentration (AUCt)
次要结局
- Urine formoterol excretion (Ae)(Over 24 h after single administration)
- Glycopyrrolate other Pharmacokinetic parameters in plasma(Over 72 h after single administration)
- B17MP and Formoterol pharmacokinetic parameters in plasma(over 24 h after single administration)
- Vital signs(over 24 h after single administration)
- Electrocardiogram (ECG) parameters(over 24 h after single administration)
- BDP pharmacokinetic parameters in plasma(over 24 h after single administration)
- Adverse events(A period of 3 to 7 weeks (from screening visit to follow-up phone call))
- Urine Glycopyrrolate excretion (Ae)(over 72 h after single administration)
研究者
研究点 (2)
Loading locations...
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