Asthma
Conditions
Brief summary
The purpose of this study is to compare Budesonide/formoterol Easyhaler test products with the marketed product Symbicort Turbuhaler in terms of the drug absorbed into the bloodstream.
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 * Body mass index \> 19 and \< 30kg/m2, weight at least 50 kg * 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 * Any condition requiring regular concomitant treatment (including vitamins and herbal products) or likely to need any concomitant treatment during a study. * Known hypersensitivity to the active substance(s) or the excipient of the drug * Pregnant and lactating females
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax of plasma budesonide and formoterol | within 24 hours |
| AUCt of plasma budesonide and formoterol | within 24 hours |
Countries
Finland
Outcome results
None listed