Phase I Randomised, Five-period Cross-over Study in Healthy Male and Female Volunteers to Compare the Pharmacokinetics of Tiotropium Delivered From Four Test pMDI Products With Spiriva Respimat

Solventum US LLC1 个研究点分布在 1 个国家目标入组 46 人开始时间: 2017年4月25日最近更新: 2024年12月2日

适应症

干预措施

试验速览

阶段: 早期 1 期
状态: 已完成
发起方: Solventum US LLC
入组人数: 46
试验地点: 1
主要终点: Peak Plasma Concentration (Cmax)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to compare the absorption of four 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 4 test inhalation products and one reference inhalation product according to a five-period cross-over design. 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)