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The primary objective of this study is to evaluate the acceptance range with which two Symbicort Turbohaler batches could be declared bioequivalent in a bioequivalence setting. The secondary objective is to compare pharmacokinetic parameters of the reference product batches and Budesonide/formoterol Easyhaler.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Symbicort Turbohaler | Experimental | Symbicort Turbohaler |
|
| Budesonide/formoterol Easyhaler | Active Comparator | Budesonide/formoterol Easyhaler |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Symbicort Turbohaler | 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 | within 12 h | |
| Pharmacokinetic parameter Cmax of plasma Formoterol concentration | within 24 h | |
| Pharmacokinetic parameter AUCt of plasma Formoterol concentration | within 24 h |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rainard Fuhr, MD | Parexel | Principal Investigator |
| Merja Mäkitalo | Orion Corporation, Orion Pharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PAREXEL International GmbH | Berlin | Germany |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D019819 | Budesonide |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| Drug |
|
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |