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The purpose of this study is to compare the test product Salmeterol/fluticasone Easyhaler with the reference product Seretide Diskus in terms of drug absorbed in the bloodstream.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Seretide Diskus and charcoal | Active Comparator | Single-dose of Seretide Diskus (50/500 mcg/inhalation) and charcoal |
|
| Seretide Diskus | Active Comparator | Single-dose of Seretide Diskus (50/500 mcg/inhalation) |
|
| SF Easyhaler and charcoal | Experimental | Salmeterol/fluticasone Easyhaler (50/500 mcg/inhalation) with charcoal |
|
| SF Easyhaler | Experimental | Salmeterol/fluticasone Easyhaler (50/500 mcg/inhalation) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Seretide Diskus and charcoal | Drug | 2 inhalations as a single dose |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic parameter Cmax of plasma salmeterol concentration | Within 34 h | |
| Pharmacokinetic parameter Cmax of plasma fluticasone propionate concentration | Within 34 h | |
| Pharmacokinetic parameter AUCt of plasma salmeterol concentration | within 34 h | |
| Pharmacokinetic parameter AUCt of plasma fluticasone propionate concentration | within 34 h |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leena Mattila, MD, PhD | Orion Corporation, Orion Pharma | Principal Investigator |
| Maria Sokka | IRW Consulting | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orion Pharma Clinical Pharmacology Unit | Espoo | Finland |
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| Seretide Diskus |
| Drug |
2 inhalations as a single dose |
|
| SF Easyhaler and charcoal | Drug | 2 inhalations as a single dose |
|
| SF Easyhaler | Drug | 2 inhalations as a single dose |
|
| 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 |
|---|---|
| D002606 | Charcoal |
| ID | Term |
|---|---|
| D002244 | Carbon |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
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