Status:
COMPLETED
Absorption of Indacaterol and Glycopyrronium From Ultibro Breezhaler
Lead Sponsor:
Orion Corporation, Orion Pharma
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
The objective of this study is to assess pharmacokinetics (PK) of indacaterol and glycopyrronium, and methodology and practical arrangements for future studies.
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, 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
Exclusion
Key Trial Info
Start Date :
May 7 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 21 2021
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT04856098
Start Date
May 7 2021
End Date
September 21 2021
Last Update
September 28 2021
Active Locations (1)
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1
CRST Helsinki Oy
Helsinki, Finland