Asthma
Conditions
Keywords
Asthma
Brief summary
The objective of the study is to assess if charcoal prevents the absorption of budesonide and formoterol via GI track. The assessment will be based on comparing the pharmacokinetic parameter area under the concentration-time curve.
Interventions
DRUGBudesonide/formoterol capsule.
Oral administration with concomitant charcoal.
DRUGBudesonide/formoterol capsule for oral adm.
Oral administration without concomitant charcoal.
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
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, gastrointestinal, 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 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 excipients of the drug. 5. Pregnant or lactating females.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The evaluation of primary pharmacokinetic variable AUCt | 4 weeks | The evaluation of primary pharmacokinetic variable AUCt of this study will be based on statistical methods appropriate for crossover design. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetic variables | 4 weeks | Cmax |
| Pharmacokinetic variable | 4 weeks | tmax |
Countries
Finland
Outcome results
None listed