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The purpose of this study is to compare absorption of salmeterol and fluticasone from Salmeterol/fluticasone Easyhaler test products to the commercially available product Seretide Diskus
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Seretide Diskus | Active Comparator | salmeterol-fluticasone 2 inhalations as a single dose |
|
| Salmeterol/fluticasone Easyhaler, E | Experimental | salmeterol-fluticasone 2 inhalations as a single dose |
|
| Salmeterol/fluticasone Easyhaler, F | Experimental | salmeterol-fluticasone 2 inhalations as a single dose |
|
| Salmeterol/fluticasone Easyhaler, G | Experimental | salmeterol-fluticasone 2 inhalations as a single dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| salmeterol-fluticasone | Drug | Seretide Diskus 50/250 µg/dose |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Peak plasma concentration (Cmax) of salmeterol | Cmax of salmeterol | between 0-34 hours after dosing |
| Peak plasma concentration (Cmax) of fluticasone propionate | Cmax of fluticasone propionate | between 0-34 hours after dosing |
| Area under the plasma concentration versus time curve (AUC) of salmeterol | AUC from time zero to the last sample with the quantifiable concentration | 0-34 hours after dosing |
| Area under the plasma concentration versus time curve (AUC) of fluticasone propionate | AUC from time zero to the last sample with the quantifiable concentration | 0-34 hours after dosing |
| Truncated area under the plasma concentration versus time curve (AUC) of salmeterol | AUC from time zero to 30 min after study treatment administration | 0-30 minutes after dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration versus time curve (AUC) of salmeterol | AUC from time zero to infinity | 0-34 hours after dosing and extrapolation |
| Area under the plasma concentration versus time curve (AUC) of fluticasone propionate |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Adverse events | through study completion, an average of 6 weeks |
Main inclusion Criteria:
Main exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ulla Sairanen | Orion Corporation, Orion Pharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Pharmacology Unit, Orion Pharma | Espoo | Finland |
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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 |
|---|---|
| D000068297 | Fluticasone-Salmeterol Drug Combination |
| ID | Term |
|---|---|
| D000068299 | Salmeterol Xinafoate |
| D000420 | Albuterol |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
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| salmeterol-fluticasone |
| Drug |
Salmeterol/fluticasone Easyhaler 50/250 µg/dose, product E |
|
| salmeterol-fluticasone | Drug | Salmeterol/fluticasone Easyhaler 50/250 µg/dose, product F |
|
| salmeterol-fluticasone | Drug | Salmeterol/fluticasone Easyhaler 50/250 µg/dose, product G |
|
AUC from time zero to infinity
| 0-34 hours after dosing and extrapolation |
| The time to reach the maximum concentration (tmax) of salmeterol | tmax of salmeterol | 0-34 hours after dosing |
| The time to reach the maximum concentration (tmax) of fluticasone propionate | tmax of fluticasone propionate | 0-34 hours after dosing |
| The terminal elimination half-life (t1/2) of salmeterol | t1/2 of salmeterol | 0-34 hours after dosing |
| The terminal elimination half-life (t1/2) of fluticasone propionate | t1/2 of fluticasone propionate | 0-34 hours after dosing |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D000438 |
| Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000068298 | Fluticasone |
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |