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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Budesonide/formoterol Easyhaler | Experimental | Budesonide/formoterol Easyhaler |
|
| Symbicort Turbuhaler | Active Comparator | Symbicort Turbuhaler |
|
| Charcoal and Budesonide/formoterol Easyhaler | Experimental |
| |
| Charcoal and Symbicort Turbuhaler | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Budesonide/formoterol Easyhaler | Drug | Budesonide/formoterol Easyhaler |
| |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Irja Korpela, MSc | Orion Corporation, Orion Pharma | Study Director |
| Rainard Fuhr, Dr. med. | Parexel Berlin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PAREXEL International GmbH | Berlin | 14050 | Germany |
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| Symbicort Turbuhaler |
| Drug |
Symbicort Turbuhaler |
|
| Charcoal and Budesonide/formoterol Easyhaler | Drug | Charcoal and Budesonide/formoterol Easyhaler |
|
| Charcoal and Symbicort Turbuhaler | Drug | Charcoal and Symbicort Turbuhaler |
|
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D019819 | Budesonide |
| D000069502 | Budesonide, Formoterol Fumarate Drug Combination |
| D002606 | Charcoal |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D000068759 | Formoterol Fumarate |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| D002244 | Carbon |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
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