Asthma
Conditions
Brief summary
The purpose of this study is to compare the test product Salmeterol/fluticasone Easyhaler with the reference product Seretide Diskus in terms of drug absorbed in the bloodstream.
Interventions
2 inhalations as a single dose
DRUGSeretide Diskus
2 inhalations as a single dose
2 inhalations as a single dose
DRUGSF Easyhaler
2 inhalations as a single dose
Sponsors
Orion Corporation, Orion Pharma
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy males and females aged 18-60 years * Normal weight, at least 50 kg
Exclusion criteria
* Evidence of clinically significant cardiovascular, renal, hepatic, haematological, GI, pulmonary, metabolic-endocrine, neurological or psychiatric disease. * Any clinically significant abnormal laboratory value or physical finding that may interfere with the interpretation of study results or constitute a health risk for the subject if he/she takes part in the study. * Any condition requiring regular concomitant treatment (including vitamins and herbal products) or likely to need any concomitant treatment during the study. * Known hypersensitivity to the active substance(s) or the excipient of the drug. * Pregnant or lactating females.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameter Cmax of plasma fluticasone propionate concentration | Within 34 h |
| Pharmacokinetic parameter AUCt of plasma salmeterol concentration | within 34 h |
| Pharmacokinetic parameter AUCt of plasma fluticasone propionate concentration | within 34 h |
| Pharmacokinetic parameter Cmax of plasma salmeterol concentration | Within 34 h |
Countries
Finland
Outcome results
None listed