Asthma
Conditions
Brief summary
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
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, hematological, GI, pulmonary, metabolic-endocrine, neurological or psychiatric disease within the previous 2 years * any condition requiring 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 | 0 hour to 34 hours after study treatment administration |
| AUCt of plasma salmeterol and fluticasone propionate | 0 hour to 34 hours after study treatment administration |
Countries
Finland
Outcome results
None listed