Pharmacokinetic Study Comparing Tiotropium Easyhaler and Spiriva Handihaler

Pharmacokinetic Pilot Study Comparing Absorption of Inhaled Tiotropium Between Tiotropium Easyhaler® Products and Spiriva® Capsules Delivered Via HandiHaler®

Absorption of inhaled tiotropium is compared between three Tiotropium Easyhaler products and Spiriva capsules inhaled via HandiHaler. All subjects will receive all products as a single dose.

Inclusion Criteria:

• Healthy male and female subjects
• 18-60 years old
• Body mass index >19 and <30 kg/m2
• Weight at least 50 kg
• Written informed consent obtained

Exclusion Criteria:

• Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, gastrointestinal, pulmonary, metabolic, endocrine, neurological or psychiatric disease.
• Any condition requiring regular concomitant treatment.
• Any clinically significant abnormal laboratory value or physical finding that in the opinion of the investigator may interfere with the interpretation of study results or constitute a health risk for the subject.
• Known hypersensitivity to tiotropium bromide, atropine or its derivatives, or lactose.
• Pregnant or lactating females and females of childbearing potential not using proper contraception.
• Blood donation, loss of a significant amount of blood or administration of another investigational medicinal product within 90 days before the first study treatment administration