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The purpose of this study is to demonstrate bioequivalence of a new formulation to a reference
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Opioid | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Bioequivalence acceptance range of 90CI of T/R ratios of AUC and Cmax. |
| Measure | Description | Time Frame |
|---|---|---|
| Descriptive, e. g. safety/tolerability of Test comparable to Reference |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wolfgang Timmer, Dr. | CRS Mannheim | Principal Investigator |
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| ID | Term |
|---|---|
| D000701 | Analgesics, Opioid |
| ID | Term |
|---|---|
| D009294 | Narcotics |
| D002492 | Central Nervous System Depressants |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
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| D020164 | Chemical Actions and Uses |
| D000700 | Analgesics |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |