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 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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Charcoal and Budesonide/formoterol Easyhaler | Experimental |
| |
| Charcoal and Symbicort Turbuhaler | Active Comparator |
| |
| Budesonide/formoterol Easyhaler | Experimental |
| |
| Symbicort Turbuhaler | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Budesonide/formoterol Easyhaler 320/9 microg | Drug | 2 inhalations as a single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic parameter Cmax of plasma budesonide concentration | within 12 h | |
| Pharmacokinetic parameter AUCt of plasma budesonide concentration | 12 h | |
| Pharmacokinetic parameter Cmax of plasma formoterol concentration | 24 h | |
| Pharmacokinetic parameter AUCt of plasma formoterol concentration | 24 h |
Not provided
Not provided
Inclusion Criteria:
Exclusion criteria
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ulla Sairanen, MSc | Orion Corporation, Orion Pharma | Study Director |
| Kimmo Ingman, MD, PhD | Orion Corporation, Orion Pharma | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orion Pharma Phase I Unit | Espoo | Finland |
Not provided
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D019819 | Budesonide |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Symbicort Turbuhaler forte | Drug | 2 inhalations as a single dose |
|
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |