NCT03945344已完成1 期
Effect of Charcoal on Gastrointestinal Absorption of Tiotropium; A Randomised, Open, Single Centre, Single Dose, Crossover Study in Healthy 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
- 20
- 试验地点
- 1
- 主要终点
- The pharmacokinetic parameter Area Under Curve (AUC)
研究概览
简要总结
The study will assess how efficiently activated charcoal will block absorption of tiotropium via the gastro intestinal track. Pharmacokinetics of tiotropium will be compared after orally administered tiotropium capsule with and without concomitant activated charcoal administration in healthy volunteers.
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
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Written informed consent (IC) obtained.
- •Healthy males and females, aged 18-60
- •Normal weight at least 50 kg.
排除标准
- •Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, gastrointestinal, pulmonary, metabolic-endocrine, neurological or psychiatric disease.
- •Any condition requiring regular concomitant treatment (including vitamins and herbal products) or likely to need any concomitant treatment during the study.
- •Any clinically significant abnormal laboratory value or physical finding that may interfere the interpretation of study result or constitute a health risk for the subject if he/she participates in the study.
- •Known hypersensitivity to tiotropium bromide, atropine or its derivatives or to the excipients of the drug.
- •Pregnant or lactating females.
- •Females of childbearing potential not using proper contraception.
研究组 & 干预措施
Treatment A
Experimental
Tiotropium with concomitant charcoal
干预措施: Tiotropium (Drug)
Treatment B
Experimental
Tiotropium without concomitant charcoal.
干预措施: Tiotropium (Drug)
结局指标
主要结局
The pharmacokinetic parameter Area Under Curve (AUC)
时间窗: 24 hours
次要结局
- Peak concentration in plasma (Cmax) and time to reach peak concentration in plasma (tmax)((0 hours) and at 15, 30 and 45 minutes, and 1,1.5, 2, 3, 3.5, 4, 4.5, 5, 6, 8, 12 and 24 hours after the administration)
研究者
研究点 (1)
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