Status:
COMPLETED
Comparison of Tiotropium Absorption From Tiotropium Easyhaler and Spiriva HandiHaler
Lead Sponsor:
Orion Corporation, Orion Pharma
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- Main inclusion criteria:
- Healthy male and female
- 18-60 years of age
- Body mass index 19-30 kg/m2
- Weight at least 50 kg
- FEV1 at least 80% of the predicted value measured at screening
- Written informed consent obtained
- Main exclusion criteria:
- Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, GI, 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 could interfere with the interpretation of study results or cause 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 contraception of acceptable effectiveness.
- Blood donation or loss of significant amount of blood within 90 days prior to the first study treatment administration.
Exclusion
Key Trial Info
Start Date :
February 16 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 3 2022
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT05246046
Start Date
February 16 2022
End Date
August 3 2022
Last Update
August 18 2022
Active Locations (1)
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1
Clinical Pharmacology Unit, Orion Corporation
Espoo, Finland