Status:
COMPLETED
Comparing Salmeterol/Fluticasone Easyhaler and Seretide Diskus (SAIMI)
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 absorption of salmeterol and fluticasone from Salmeterol/fluticasone Easyhaler test products to the commercially available product Seretide Diskus
Eligibility Criteria
Inclusion
- Main inclusion Criteria:
- Written informed consent (IC) obtained.
- Males and females, 18-60 (inclusive) years of age.
- Normal weight defined as body mass index (BMI) 19-30 kg/m2 (BMI = weight/height2).
- Weight at least 50 kg.
- 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 may interfere with the interpretation of study results or constitute a health risk for the subject if he/she takes part in the study.
- Known hypersensitivity to the active substance(s) or the lactose.
- Pregnant or lactating females and females of childbearing potential not using proper contraception.
- Blood donation or loss of significant amount of blood within 90 days prior to first study treatment administration.
- Administration of another investigational medicinal product within 90 days prior to first study treatment administration.
Exclusion
Key Trial Info
Start Date :
August 16 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 19 2017
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT03238482
Start Date
August 16 2017
End Date
December 19 2017
Last Update
April 6 2018
Active Locations (1)
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1
Clinical Pharmacology Unit, Orion Pharma
Espoo, Finland