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The purpose of this study is to compare the test product Budesonide/formoterol Easyhaler with the marketed product Symbicort Turbohaler in terms of the drug absorbed into the bloodstream.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Budesonide/formoterol Easyhaler | Experimental |
| |
| Charcoal and Budesonide/formoterol EH | Experimental |
| |
| Symbicort Turbohaler | Active Comparator |
| |
| Charcoal and Symbicort Turbohaler | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| budesonide and formoterol 200/6 microg | Drug | 2 inhalations as a single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic parameters Cmax and AUCt of plasma budesonide and formoterol concentrations | within 24 h |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ulla Sairanen, MSc | Orion Corporation, Orion Pharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medicines Evaluation Unit | Manchester | M23 9QZ | United Kingdom |
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| budesonide and formoterol 200/6 microg | Drug | 2 inhalations as a single dose |
|
|
| budesonide and formoterol 200/6 microg | Drug | 2 inhalations as a single dose with the concurrent charcoal blockage |
|
|
| budesonide and formoterol 200/6 microg | Drug | 2 inhalations as a single dose with the concurrent charcoal blockage |
|
|
| 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 |
| D001239 | Inhalation |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D015656 | Respiratory Mechanics |
| D012119 | Respiration |
| D012143 | Respiratory Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
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