NCT03246581已完成1 期
Protocol With Amendments 1 and 2: Phase I Randomised, Two-period 21 Day Crossover Study in Healthy Male and Female Volunteers to Compare the Steadystate Pharmacokinetics of Tiotropium Delivered From a Test pMDI Product With Spiriva Respimat
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
- 40
- 试验地点
- 1
- 主要终点
- Peak Plasma Concentration (Cmax)
研究概览
简要总结
The purpose of this study is to compare the absorption of a test inhalation product with the reference product in healthy volunteers.
详细描述
Healthy subjects will be enrolled and will receive doses of a test inhalation product and a reference inhalation product for 28 days according to a crossover design. Plasma tiotropium levels will be measured predose and over 24 hours postdose on days 1 and 28.
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
研究组 & 干预措施
Test Product
Experimental
tiotropium pMDI 2 inhalations
干预措施: Tiotropium (Drug)
Commercial Product
Active Comparator
tiotropium pMDI 2 inhalations
干预措施: Tiotropium (Drug)
结局指标
主要结局
Peak Plasma Concentration (Cmax)
时间窗: 24 hours
noncompartmental analysis
次要结局
未报告次要终点
研究者
研究点 (1)
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