ACTRN12615000073505已完成1 期
A single dose, randomized, open label, bioavailability study of tiotropium test product 1 and tiotropium test product 2 in a 3 way crossover comparison against the innovator Spiriva HandiHaler conducted under fasting conditions in healthy male and female volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 45 Years（—）
- 性别
- All
入选标准
- •Healthy male and non-pregnant females
- •Aged between 18 and 45
- •Non-smoker
- •BMI between 18.5 and 30 inclusive
- •Normal, healthy individuals as determined by medical history, physical examination, ECG, blood pressure, spirometry, oximetry and laboratory tests
- •Able to provide written informed consent
排除标准
- •Any history of recent recurrent attacks of bronchitis, COPD, asthma, migraine headaches
- •Concomitant drug therapy of any kind
- •Sensitivity to tiotropium or any other similar class of medicines, or the excipients of tiotropium
- •Who have a history of known allergy to milk protein or food allergy
- •History of any conditions that might interfere with the absorption, distribution, metabolism or excretion of the drug
- •Females who are pregnant and/or are breastfeeding
- •Smoker (anyone who has smoked in the last 6 months)
- •History of alcohol or drug abuse or dependency
- •Participation in a drug study within 60 days of the start of the study or donated blood in the 60 days preceding the study.
- •Volunteers for whom the Clinical Investigator believes, for any reason, that participation would not be an acceptable risk
研究者
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