Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to compare the test product Budesonide/formoterol Easyhaler with the marketed product Symbicort Turbuhaler in terms of the drug absorbed into the bloodstream.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Charcoal and Symbicort Turbuhaler | Active Comparator |
| |
| Symbicort Turbuhaler | Active Comparator |
| |
| Charcoal and Budesonide/formoterol Easyhaler | Experimental |
| |
| Budesonide/formoterol Easyhaler | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Charcoal and Budesonide/formoterol Easyhaler 320/9 microg | Drug | 2 inhalations as a single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic parameter Cmax of plasma budesonide concentration | within 12 h | |
| Pharmacokinetic parameter Cmax of plasma formoterol concentration | within 24 h | |
| Pharmacokinetic parameter AUCt of plasma budesonide concentration | Within 12 h | |
| Pharmacokinetic parameter AUCt of plasma formoterol concentration | Within 24 h |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Leena Mattila, MD, PhD | Orion Corporation, Orion Pharma | Principal Investigator |
| Ulla Sairanen, MSc | Orion Corporation, Orion Pharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orion Pharma Clinical Pharmacology Unit | Espoo | Finland |
Not provided
Not provided
Not provided
Not provided
Not provided
| Charcoal and Symbicort Turbuhaler | Drug | 2 inhalations as a single dose |
|
| Budesonide/formoterol Easyhaler 320/9 microg | Drug | 2 inhalations as a single dose |
|
| Symbicort Turbuhaler forte | 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D002606 | Charcoal |
| D019819 | Budesonide |
| D000069502 | Budesonide, Formoterol Fumarate Drug Combination |
| ID | Term |
|---|---|
| D002244 | Carbon |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | 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 |
Not provided
Not provided