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The purposes of this study is to compare the test products Salmeterol/fluticasone Easyhaler with marketed product Seretide Diskus in terms of the drug absorbed into the blood stream
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Salmeterol/fluticasone Easyhaler | Experimental | Single dose of Salmeterol/fluticasone Easyhaler |
|
| Salmeterol/fluticasone Easyhaler with charcoal | Experimental | Single dose of Salmeterol/fluticasone Easyhaler with concomitant charcoal administration (Carbomix granules) |
|
| Seretide Diskus | Active Comparator | Single dose of Seretide Diskus |
|
| Seretide Diskus with charcoal | Active Comparator | Single dose of Seretide Diskus with concomitant charcoal administration (Carbomix granules) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Salmeterol/fluticasone Easyhaler | Drug |
| ||
| Salmeterol/fluticasone Easyhaler with charcoal |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of plasma salmeterol and fluticasone propionate | within 34 h | |
| AUCt of plasma salmeterol and fluticasone propionate | 34 h |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Merja Mäkitalo | Orion Corporation, Orion Pharma | Study Director |
| Leena Mattila, MD, PhD | Orion Pharma Clinical Pharmacology Unit, Espoo, Finland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orion Pharma Pharmacology Unit | Espoo | Finland |
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| Drug |
|
| Seretide Diskus | Drug |
|
| Seretide Diskus with charcoal | Drug |
|
| 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 |
|---|---|
| D000068299 | Salmeterol Xinafoate |
| D002606 | Charcoal |
| ID | Term |
|---|---|
| D000420 | Albuterol |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D002244 | Carbon |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
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