Healthy Volunteers
Conditions
Brief summary
This is a pivotal study to investigate absorption of inhaled tiotropium from 2 Tiotropium Easyhaler product variants and Spiriva capsules inhaled via HandiHaler.
Interventions
In each period, subjects receive single dose of tiotropium consisting of 2 inhaled doses via Easyhaler or 2 Spiriva capsules inhaled via HandiHaler
Sponsors
Orion Corporation, Orion Pharma
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Masking description
Bioanalytical laboratory will be blinded with regard to the sequence of the product administration
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peak tiotropium concentration in plasma (Cmax) | between 0-72 hours after dosing |
| Area under the concentration-time curve from time zero to 30 minutes (AUC30 minutes) | between 0-30 minutes after dosing |
| Area under the concentration-time curve from time zero to 72 hours (AUC72 hours) | between 0-72 hours after dosing |
Secondary
| Measure | Time frame |
|---|---|
| Time to reach peak concentration in plasma (tmax) | between 0-72 hours after dosing |
Other
| Measure | Time frame |
|---|---|
| Adverse events | throughout the study, an average 7 weeks |
Countries
Finland
Outcome results
None listed