Healthy
Conditions
Keywords
Healthy volunteer study
Brief summary
The aim of the study is to assess and compare the Pharmacokinetic (PK) of Budesonide and Formoterol after administration of 3 different product variants of Budesonide/Formoterol Easyhalers and Symbicort turbuhaler.
Interventions
DRUGBudesonide
Single inhalation
DRUGFormoterol
Single inhalation
DEVICEEasyhaler
Inhaler device
DEVICETurbohaler Forte
Inhaler device
Sponsors
Orion Corporation, Orion Pharma
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy males and females, 18-55 years of age. * Normal weight at least 50 kg.
Exclusion criteria
* Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, gastrointestinal, pulmonary, metabolic-endocrine, neurological or psychiatric disease. * Any condition requiring concomitant treatment (including vitamins and herbal products)or likely to need any concomitant treatment during the study * Any 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. * Known hypersensitivity to the active substance(s) or to any of the excipients of the drug. * Pregnant or lactating females.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax of Budesonide and Formoterol | 24 hours |
| AUCt of Budesonide and Formoterol | 24 hours |
Secondary
| Measure | Time frame |
|---|---|
| AUCinf of Budesonide and Formoterol | 24 hours |
| tmax of Budesonide and Formoterol | 24 hours |
| t1/2 of Budesonide and Formoterol | 24 hours |
Countries
Germany
Outcome results
None listed