Comparison of Tiotropium Absorption From Tiotropium Easyhaler and Spiriva HandiHaler

Launched by ORION CORPORATION, ORION PHARMA · Feb 17, 2022

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Gender

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Eligibility criteria

• Main inclusion criteria:
• • 1. Healthy male and female
• • 2. 18-60 years of age
• • 3. Body mass index 19-30 kg/m2
• • 4. Weight at least 50 kg
• • 5. FEV1 at least 80% of the predicted value measured at screening
• • 6. Written informed consent obtained
• Main exclusion criteria:
• • 1. Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, GI, pulmonary, metabolic, endocrine, neurological or psychiatric disease.
• • 2. Any condition requiring regular concomitant treatment.
• • 3. Any clinically significant abnormal laboratory value or physical finding that in the opinion of the investigator could interfere with the interpretation of study results or cause a health risk for the subject.
• • 4. Known hypersensitivity to tiotropium bromide, atropine or its derivatives or lactose.
• • 5. Pregnant or lactating females and females of childbearing potential not using contraception of acceptable effectiveness.
• • 6. Blood donation or loss of significant amount of blood within 90 days prior to the first study treatment administration.