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The objective of the study is to assess the extent to which the charcoal prevents the absorption of salmeterol and fluticasone via the GI tract. The assessment will be based on comparing the pharmacokinetic parameter area under the concentration-time curve (AUCt).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Experimental | Salmeterol/fluticasone propionate with concomitant charcoal |
|
| Treatment B | Experimental | Salmeterol/fluticasone propionate without concomitant charcoal |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| salmeterol / fluticasone propionate | Drug | 100/1000 μg oral capsule |
|
| Measure | Description | Time Frame |
|---|---|---|
| The pharmacokinetic parameter Area Under Curve (AUC) time frame: predose and 0:15, 0:30, 0:45, 1:00, 1:20, 1:40, 2:00, 4:00, 6:00, 8:00, 10:00, 12:00 and 24:00 hours post-dose. | The evaluation of primary pharmacokinetic variable AUCt of this study will be based on statistical methods appropriate for crossover study design. | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| The pharmacokinetic variables Cmax and tmax time frame: predose and 0:15, 0:30, 0:45, 1:00, 1:20, 1:40, 2:00, 4:00, 6:00, 8:00, 10:00, 12:00 and 24:00 hours post-dose. | 24 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mika Scheinin, MD, PhD | Clinical Research Services Turku Finland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CRST (Clinical Research Services Turku) | Turku | Finland |
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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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| 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 |