Comparison of Tiotropium Absorption From Tiotropium Easyhaler and Spiriva HandiHaler

Pharmacokinetic Study to Compare Tiotropium Easyhaler® Product Variants and Spiriva® 18 µg Capsules Administered Via HandiHaler® in Healthy Volunteers.

This is a pivotal study to investigate absorption of inhaled tiotropium from 2 Tiotropium Easyhaler product variants and Spiriva capsules inhaled via HandiHaler.

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.