EUCTR2013-002557-30-Outside-EU/EEA进行中（未招募）不适用
A two-staged, open label, single dose, two period, two-sequence,crossover study to compare the bioavailability of 2 mg GlycopyrroniumBromide from a new oral solution (2 mg/5 ml) (Test Product) with thatof 2 mg Glycopyrronium Bromide from Cuvposa (1 mg/5 ml) Solution(Reference product) in at least 36 healthy male and female subjectsunder fasting conditions.
Proveca Ltd0 个研究点目标入组 36 人开始时间: 2014年3月18日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Healthy volunteers:
- •Age: = 18 to = 50 years
- •Sex: Male or female
- •Status: Healthy volunteers with a body mass index of =20, =30kg/m2
- •Subjects who give written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 36
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Known allergy to glycopyrronium bromide or any of the excipients.
- •Refusal to give informed consent
- •Use of glycopyrronium bromide liquid within approximately 24 hours prior to baseline
- •Use of any of the prohibited anticholinergic or cholinergic medications specified in the protocol within three plasma half-lives of the medication prior to baseline
- •Medical conditions contraindicating anticholinergic therapy including: Glaucoma, obstructive uropathy, uretovesicular reflux, reactive airway disease, myasthenia gravis, hyperthyroidism, cardiac arrhythmias and/or tachycardia, and/or clinically significant ECG abnormalities as determined by the investigator.
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