Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Budesonide/Formoterol Easyhaler A | Experimental |
| |
| Budesonide/Formoterol Easyhaler B | Experimental |
| |
| Budesonide/Formoterol Easyhaler C | Experimental |
| |
| Budesonide/Formoterol Turbohaler Forte | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Budesonide | Drug | Single inhalation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of Budesonide and Formoterol | 24 hours | |
| AUCt of Budesonide and Formoterol | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| AUCinf of Budesonide and Formoterol | 24 hours | |
| tmax of Budesonide and Formoterol | 24 hours | |
| t1/2 of Budesonide and Formoterol |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Johanna Hietamäki, MSc | Orion Corporation, Orion Pharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parexel International GmbH | Berlin | Germany |
Not provided
| ID | Term |
|---|---|
| D019819 | Budesonide |
| D000068759 | Formoterol Fumarate |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Formoterol | Drug | Single inhalation |
|
| Easyhaler | Device | Inhaler device |
|
| Turbohaler Forte | Device | Inhaler device |
|
| 24 hours |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |