Status:
COMPLETED
Study to Compare Relative Bioavailability of 3 Indacaterol/Glycopyrronium Test Products and Reference Product
Lead Sponsor:
Orion Corporation, Orion Pharma
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
This is a formulation feasibility study to to compare relative bioavailability of indacaterol and glycopyrronium after administration of single doses of 3 Easyhaler test products and Ultibro Breezhale...
Eligibility Criteria
Inclusion
- Main
- 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
- 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, vital sign 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 indacaterol or glycopyrronium
- 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
Key Trial Info
Start Date :
February 28 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 27 2022
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT05288075
Start Date
February 28 2022
End Date
June 27 2022
Last Update
July 13 2022
Active Locations (1)
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1
CRST Helsinki Oy
Helsinki, Finland