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This study will compare the relative bioavailability (rate and extent of absorption) of 500 mg Divalproex Sodium (equivalent to 500 mg Valproic Acid) Extended Release Tablets with that of Depakote® ER Tablets following a single oral dose (1 x 500 mg tablet) in healthy adult subjects administered under fasting conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Divalproex Sodium | Experimental | 500 mg Extended Release Tablet |
|
| Depakote® | Active Comparator | 500 mg Extended Release Tablet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Divalproex Sodium | Drug | 500 mg Extended Release Tablet |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax - Maximum Observed Concentration | Blood samples collected over 72 hour period | |
| AUC0-inf - Area under the concentration-time curve from time zero to infinity (extrapolated) | Blood samples collected over 72 hour period | |
| AUC0-t - Area under the concentration-time curve from time zero to time of last quantifiable concentration (per participant) | Blood samples collected over 72 hour period |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| James D Carlson, Pharm. D | PRACS Institute, Ltd. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PRACS Institute, Ltd. | Fargo | North Dakota | 58104 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 10, 2009 | |
| Reset | Oct 14, 2009 | |
| Release | Aug 19, 2024 | |
| Reset | Oct 30, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 10, 2009 | Oct 14, 2009 | |||
| Aug 19, 2024 |
| ID | Term |
|---|---|
| D014635 | Valproic Acid |
| ID | Term |
|---|---|
| D010421 | Pentanoic Acids |
| D014631 | Valerates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
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| Depakote® |
| Drug |
500 mg Extended Release Tablet |
|
| Oct 30, 2024 |
| D009930 |
| Organic Chemicals |
| D005232 | Fatty Acids, Volatile |
| D005227 | Fatty Acids |
| D008055 | Lipids |