Asthma
Conditions
Brief summary
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
Interventions
Sponsors
Orion Corporation, Orion Pharma
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Written informed consent obtained * Good general health ascertained by detailed medical history, and laboratory and physical examinations
Exclusion criteria
* Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, GI, pulmonary, metabolic-endocrine, neurological or psychiatric disease within the previous 2 years * Any condition requiring regular concomitant treatment (including vitamins and herbal products) or likely to need any concomitant treatment during the study. As an exception, paracetamol and ibuprofen for occasional pain are allowed * Known hypersensitivity to the active substance(s) or the excipient (lactose, which contains small amounts of milk protein) of the drug * Pregnant or lactating females
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax of plasma salmeterol and fluticasone propionate | within 34 h |
| AUCt of plasma salmeterol and fluticasone propionate | 34 h |
Countries
Finland
Outcome results
None listed