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.
- Conditions
- COPD10006436
- Registration Number
- NL-OMON44319
- Lead Sponsor
- Phargentis SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 18
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).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>* The area under the plasma concentration-time curve from time zero to time t<br /><br>of the last measured concentration above the limit of quantification (AUC0-t).<br /><br>* The area under the plasma concentration-time curve from zero to infinity<br /><br>(AUC0-*).<br /><br>* The maximum plasma concentration (Cmax).<br /><br>* The time to reach maximum plasma concentration (tmax).<br /><br>* The terminal elimination rate constant (*z) with the respective half-life<br /><br>(t*). </p><br>
- Secondary Outcome Measures
Name Time Method <p>* (Treatment emergent) adverse events<br /><br>* Physical examination<br /><br>* Vital signs<br /><br>* ECG<br /><br>* Spirometry<br /><br>* Clinical safety laboratory</p><br>