NCT02676297已完成1 期
Phase I Randomised, Three-period Cross-over Study in Healthy Male and Female Volunteers to Compare the Pharmacokinetics of Tiotropium Delivered From Two Test Products With Spiriva Respimat Comparator Product
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
- 26
- 试验地点
- 1
- 主要终点
- peak plasma concentration
研究概览
简要总结
The purpose of this study is to compare the absorption of two different inhalation products with the reference product in healthy volunteers.
详细描述
Healthy subjects will be enrolled and will receive single doses of 2 test inhalation products and one reference inhalation product according to a three-period cross-over design. Subjects will use the patient instruction leaflet to understand how each inhaler is administered. Plasma tiotropium levels will be measured pre-dose and over 8 hours post-dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Volunteer
- •Willing and able to give informed consent
- •Willing to withhold all alcoholic beverages for 48 hours and all xanthine- containing foods and beverages for 24 hours prior to reporting to clinic
- •Subjects must agree to use an adequate method of contraception from admission through 12 weeks after last administration
排除标准
- •Evidence or history of clinically significant abnormalities or disease or chronic respiratory disorders
- •Any presence or history of a clinically significant allergy including any adverse reaction to study drug
- •History of drug or alcohol abuse within the past 2 years
- •Smoked tobacco within the past 6 months or have a history of more than 10- pack years (number of packs smoked per day x number of years smoked)
- •Donation or loss of greater than 400 mL of blood within the previous 3 months
- •Have received any prescription medication within 4 weeks or investigational medication within 12 weeks of study (exception: contraceptives are permitted)
- •Have received any non-prescription medication within 14 days prior to dosing (exception: paracetamol use within 2 days)
- •Upper respiratory tract infection (excluding otitis media) within 14 days of the first study day, or lower respiratory tract infection within the last 3 months
- •If female, nursing, lactating or pregnant
- •Regular alcohol consumption in males >21 units per week and females >14 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine)
研究组 & 干预措施
Test product A
Experimental
tiotropium
干预措施: tiotropium (Drug)
Test product B
Experimental
tiotropium
干预措施: tiotropium (Drug)
reference product
Active Comparator
tiotropium
干预措施: tiotropium (Drug)
结局指标
主要结局
peak plasma concentration
时间窗: 8 hours
measured by noncompartmental analysis
次要结局
- adverse events(8 hours)
研究者
研究点 (1)
Loading locations...
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