Status:
COMPLETED
Comparison of Salmeterol and Fluticasone Propionate Absorption From Salmeterol/Fluticasone Easyhaler With Seretide Diskus
Lead Sponsor:
Orion Corporation, Orion Pharma
Conditions:
Asthma
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to compare the test product Salmeterol/fluticasone Easyhaler with the reference product Seretide Diskus in terms of drug absorbed in the bloodstream.
Eligibility Criteria
Inclusion
- Healthy males and females aged 18-60 years
- Normal weight, at least 50 kg
Exclusion
- Evidence of clinically significant cardiovascular, renal, hepatic, haematological, GI, pulmonary, metabolic-endocrine, neurological or psychiatric disease
- Any clinically significant abnormal laboratory value or physical finding that may interfere with the interpretation of study results or constitute a health risk for the subject if he/she takes part in the study
- Any condition requiring regular concomitant treatment (including vitamins and herbal products) or likely to need any concomitant treatment during the study
- Known hypersensitivity to the active substance(s) or the excipient of the drug
- Pregnant or lactating females
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2013
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT01856621
Start Date
May 1 2013
End Date
September 1 2013
Last Update
January 3 2014
Active Locations (1)
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1
Orion Pharma Clinical Pharmacology Unit
Espoo, Finland