Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00974012 | Divalproex Sodium 500 mg Extended Release Tablets Under Non-Fasting Conditions | PHASE1 | COMPLETED | 24 | — | — | Oct 1, 2006 | Oct 1, 2006 | Sep 10, 2009 | 1 | United States |
| NCT00974441 | Divalproex Sodium 500 mg Extended Release Tablets Under Fasting Conditions | PHASE1 | COMPLETED | 48 | — | — | Aug 1, 2006 | Sep 1, 2006 | Sep 10, 2009 | 1 | United States |
| NCT00834639 | Divalproex Sodium Delayed-Release Tablets Under Fasting Conditions | PHASE1 | COMPLETED | 24 | — | — | Sep 1, 2003 | Sep 1, 2003 | Aug 20, 2009 | 1 | United States |
| NCT00834990 | Divalproex Sodium Delayed-Release Tablets Under Non-Fasting Conditions | PHASE1 | COMPLETED | 24 | — | — | Sep 1, 2003 | Sep 1, 2003 | Aug 20, 2009 | 1 | United States |
Bioequivalence based on Cmax.
Bioequivalence based on AUC0-t.
Bioequivalence based on AUC0-inf.
| Arm | Type | Description |
|---|---|---|
| Divalproex Sodium | EXPERIMENTAL | 500 mg Extended Release Tablet |
| Depakote® | ACTIVE_COMPARATOR | 500 mg Extended Release Tablet |
| 1 | EXPERIMENTAL | - |
| 2 | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Divalproex Sodium | DRUG | 500 mg ER Tablet |
| Depakote® | DRUG | 500 mg ER Tablet |
Inclusion Criteria * Subjects who have completed the screening process within 28 days prior to Period 1 dosing * Subjects who are healthy adult men and women 18 years of age or older at the time of dosing. * Subjects who have a body mass index (BMI) between 19-30 kg/m2, inclusive, and weigh at leas...