Comparing Salmeterol/Fluticasone Easyhaler and Seretide Diskus (SAIMI)
NCT03238482 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 64
Last updated 2018-04-06
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
Conditions
Interventions
- DRUG
-
salmeterol-fluticasone
Seretide Diskus 50/250 µg/dose
- DRUG
-
salmeterol-fluticasone
Salmeterol/fluticasone Easyhaler 50/250 µg/dose, product E
- DRUG
-
salmeterol-fluticasone
Salmeterol/fluticasone Easyhaler 50/250 µg/dose, product F
- DRUG
-
salmeterol-fluticasone
Salmeterol/fluticasone Easyhaler 50/250 µg/dose, product G
Sponsors & Collaborators
-
Orion Corporation, Orion Pharma
lead INDUSTRY
Principal Investigators
-
Ulla Sairanen · Orion Corporation, Orion Pharma
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2017-08-16
- Primary Completion
- 2017-12-19
- Completion
- 2017-12-19
Countries
- Finland
Study Locations
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