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To demonstrate the relative bioavailability of Divalproex Sodium 500 mg delayed release tablets under fasting conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Divalproex Sodium 500 mg DR Tablets (Sandoz Inc., USA) |
|
| 2 | Active Comparator | Depakote 500 mg DR Tablets (Abbott Laboratories, USA) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Divalproex Sodium 500 mg DR Tablets (Sandoz Inc., USA) | Drug |
| ||
| Depakote 500 mg DR Tablets (Abbott Laboratories, USA) |
| Measure | Description | Time Frame |
|---|---|---|
| Bioequivalence based on AUC and Cmax | 10 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xueya (Eric) Chen, M.D. | Pharma Medica Research, Inc. | Principal Investigator |
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| Drug |
|
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D014635 | Valproic Acid |
| ID | Term |
|---|---|
| D010421 | Pentanoic Acids |
| D014631 | Valerates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D005232 | Fatty Acids, Volatile |
| D005227 | Fatty Acids |
| D008055 | Lipids |
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