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This is a Phase 1, open-label, randomized, single-dose, 2-way crossover study in healthy adult subjects to assess the bioequivalence of naltrexone SR/bupropion SR combination trilayer tablets prepared at two different manufacturing sites. The pharmacokinetics of the two drug products will be evaluated separately in the fed and fasted state.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fed Group | Active Comparator | Reference and test product naltrexone SR/bupropion SR combination trilayer tablets tested in the fed state. |
|
| Fasted group | Active Comparator | Reference and test product naltrexone SR/bupropion SR combination trilayer tablets tested in the fasted state. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reference naltrexone 8 mg SR/bupropion 90 mg SR combination trilayer tablets (2 tablets) | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Maximum observed plasma concentration | 0-96 hours post-dose |
| AUC(0-t) | Area under the plasma concentration-time curve from 0 hour to the time of the last quantifiable concentration | 0-96 hours post-dose |
| AUC(0-inf) | Area under the plasma concentration-time curve from 0 hour extrapolated to infinity | 0-96 hours post-dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Senior Vice President Head of Global Development | Orexigen Therapeutics, Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quintiles Phase One Services, LLC | Overland Park | Kansas | 66211 | United States |
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| Test naltrexone 8 mg SR/bupropion 90 mg SR combination trilayer tablets (2 tablets) | Drug |
|
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000591595 | bupropion hydrochloride, naltrexone hydrochoride drug combination |
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