Asthma
Conditions
Brief summary
The purpose of this study is to compare the test product Budesonide/formoterol Easyhaler with the marketed product Symbicort Turbohaler in terms of the drug absorbed into the bloodstream.
Interventions
DRUGbudesonide and formoterol 200/6 microg
2 inhalations as a single dose
Sponsors
Orion Corporation, Orion Pharma
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Males or females aged 18-60 years with documented diagnosis of asthma * Prebronchodilator forced expiratory volume in one second (FEV1) at least 80% of the predicted value * The asthma should be stable on the same regular treatment for at least 4 weeks before screening.
Exclusion criteria
* Use of oral, parenteral or rectal corticosteroids within 4 weeks preceding the screening * Respiratory infection within 4 weeks preceding the screening * Any condition requiring regular concomitant treatment or likely to need concomitant treatment during the study with medicinal products which have pharmacokinetic interactions with budesonide * Any disorder or clinically significant abnormal laboratory value or physical finding that may interfere with the interpretation of test results or cause a health risk for the subject if he/she participates in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters Cmax and AUCt of plasma budesonide and formoterol concentrations | within 24 h |
Countries
United Kingdom
Outcome results
None listed