Asthma
Conditions
Brief summary
The purpose of this study is to compare the test product Budesonide/formoterol Easyhaler with the marketed product Symbicort Turbuhaler in terms of the drug absorbed into the bloodstream.
Interventions
DRUGCharcoal and Budesonide/formoterol Easyhaler 320/9 microg
2 inhalations as a single dose
2 inhalations as a single dose
2 inhalations as a single dose
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
Yes
Inclusion criteria
1. Healthy males and females aged 18-60 years. 2. Normal weight, at least 50 kg.
Exclusion criteria
1. Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, GI, pulmonary, metabolic-endocrine, neurological or psychiatric disease. 2. 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. 3. Any condition requiring regular concomitant treatment (including vitamins and herbal products) or likely to need any concomitant treatment during the study. 4. Known hypersensitivity to the active substance(s) or the excipient of the drug. 5. Pregnant or lactating females.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameter Cmax of plasma budesonide concentration | within 12 h |
| Pharmacokinetic parameter Cmax of plasma formoterol concentration | within 24 h |
| Pharmacokinetic parameter AUCt of plasma budesonide concentration | Within 12 h |
| Pharmacokinetic parameter AUCt of plasma formoterol concentration | Within 24 h |
Countries
Finland
Outcome results
None listed