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Pharmacokinetic Study Comparing Salmeterol/Fluticasone Easyhaler Products and Seretide Diskus 50/500 µG/Inhalation; A Randomised, Open, Single Centre, Single Dose, Crossover Study in Healthy Subjects
The purposes of this study is to compare the test products Salmeterol/fluticasone Easyhaler with marketed product Seretide Diskus in terms of the drug absorbed into the blood stream
Details
| Lead sponsor | Orion Corporation, Orion Pharma |
|---|---|
| Phase | Phase 1 |
| Status | COMPLETED |
| Enrolment | 129 |
| Start date | 2014-06 |
| Completion | 2015-09 |
Conditions
- Asthma
Interventions
- Salmeterol/fluticasone Easyhaler
- Salmeterol/fluticasone Easyhaler with charcoal
- Seretide Diskus
- Seretide Diskus with charcoal
Primary outcomes
- Cmax of plasma salmeterol and fluticasone propionate — within 34 h
- AUCt of plasma salmeterol and fluticasone propionate — 34 h
Countries
Finland