Status:
COMPLETED
Pharmacokinetic Study Comparing Tiotropium Easyhaler® and Spiriva® HandiHaler®
Lead Sponsor:
Orion Corporation, Orion Pharma
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
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 betwe...
Eligibility Criteria
Inclusion
- Main inclusion criteria:
- Healthy males and females
- 18-60 years of age
- Body mass index 19-30 kg/m2
- Weight at least 50 kg
- Written informed consent obtained
- Main 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 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 :
April 26 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 4 2021
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT04850144
Start Date
April 26 2021
End Date
October 4 2021
Last Update
October 25 2021
Active Locations (1)
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1
Clinical Pharmacology Unit, Orion Corporation
Espoo, Finland