Healthy Volunteers
Conditions
Brief summary
Absorption of inhaled tiotropium is compared between five Tiotropium Easyhaler product variants and Spiriva capsules inhaled via HandiHaler without charcoal. Absorption of tiotropium is compared between one Easyhaler product variant administered with and without charcoal.
Interventions
Tiotropium Easyhaler 10 µg/dose Product variant D
DRUGTiotropium Easyhaler with oral activated charcoal
The charcoal suspension will be administered orally with Tiotropium Easyhaler 10 µg/dose Product variant F
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.
Intervention model description
The study is a 2-part 4-period crossover study where the study subjects participate either in part 1 (20 subjects) or in part 2 (20 subjects). Parts can run in sequence or parallel. All study subjects receive single dose of Tiotropium Easyhaler on 3 periods and Spiriva HandiHaler on 1 period.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
Main inclusion criteria: 1. Healthy males and females 2. 18-60 years of age 3. Body mass index 19-30 kg/m2 4. Weight at least 50 kg 5. Written informed consent obtained Main
Exclusion criteria
1. Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, gastrointestinal, 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) | 0-30 minutes after dosing |
| Area under the concentration-time curve from time zero to 72 hours (AUC72 hours) | 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 | througout the study, an average 9 weeks |
Countries
Finland
Outcome results
None listed