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The aim of this pilot study is to assess the methodology, practical arrangements and pulmonary absorption with charcoal blockage for the future bioequivalence studies. In addition, PK of budesonide and formoterol after administration from 2 different batches of Symbicort TH is compared with each other.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Budesonide/Formoterol Batch 1 |
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| 2 | Experimental | Budesonide/Formoterol Batch 2 |
|
| 3 | Experimental | Budesonide/Formoterol Batch 1 and charcoal |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Budesonide/Formoterol Batch 1 | Drug | Single, inhaled dose |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Assess the methodology, practical arrangements and pulmonary absorption with charcoal blockage | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of budesonide and formoterol after administration of two different batches of Symbicort Turbuhaler | 1 day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kimmo Ingman, MD, PhD | Orion Corporation, Orion Pharma | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orion Pharma Phase I Unit | Espoo | 02101 | Finland |
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| ID | Term |
|---|---|
| D019819 | Budesonide |
| D000069502 | Budesonide, Formoterol Fumarate Drug Combination |
| D002606 | Charcoal |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| Budesonide/Formoterol Batch 2 | Drug | Single, inhaled dose |
|
|
| Budesonide/Formoterol Batch 1 and charcoal | Drug | Single, inhaled dose |
|
|
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D000068759 | Formoterol Fumarate |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| D002244 | Carbon |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |