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The objective of the study is to assess if charcoal prevents the absorption of budesonide and formoterol via GI track. The assessment will be based on comparing the pharmacokinetic parameter area under the concentration-time curve.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Experimental | Budesonide/formoterol capsule (Orion Pharma) for oral administration. |
|
| Treatment B | Experimental | Budesonide/formoterol capsule (Orion Pharma) for oral administration. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Budesonide/formoterol capsule. | Drug | Oral administration with concomitant charcoal. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The evaluation of primary pharmacokinetic variable AUCt | The evaluation of primary pharmacokinetic variable AUCt of this study will be based on statistical methods appropriate for crossover design. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic variables | Cmax | 4 weeks |
| Pharmacokinetic variable | tmax | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mika Scheinin, M.D.Ph.D | Clinical Research Services Turku Finland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Reseach Services Turku (CRST) | Turku | 20520 | 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 |
|---|---|
| D019819 | Budesonide |
| D000068759 | Formoterol Fumarate |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| Budesonide/formoterol capsule for oral adm. |
| Drug |
Oral administration without concomitant charcoal. |
|
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |