An open label, randomized, single inhaled dose, three-way cross over pilot study to compare the pharmacokinetic profiles of different dry powder inhalers with tiotropium bromide in healthy volunteers. - PGTB001

Phargentis SA0 个研究点目标入组 18 人开始时间: 待定最近更新: 2024年4月15日

适应症

试验速览

暂无简介。

•1. Subjects must be healthy male or female subjects 18-50 years of age, inclusive.
•2. Subjects must have normal lung function at Screening and prior to first dosing according to the investigator, e.g. FEV1 * 80% of the predicted normal value (inclusive).
•3. Subject must be able to adequately follow the inhalation instructions and inhale correctly through both devices.

•1. A history of a clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary or major neurological (including stroke and chronic seizures) or any other clinically significant abnormality or disease.
•2. An upper and/or lower respiratory tract infection within 3 weeks of Screening.
•3. Any chronic and/or symptomatic upper or lower airway disease such as asthma, COPD, bronchiectasis, sarcoidosis, lung cancer, allergic airway disease (e.g. pollen allergy inside the relevant season or symptomatic to pets while daily exposed to them).
•4. Current smokers (smoked in the previous 12 months or stopped smoking less than 12 months prior to Screening) or ex-smokers with more than 10 pack-year smoking history (e.g., at least 1 pack/day for 10 years, or 2 packs/day for 5 year).

发起方

Phargentis SA