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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00864006 | Bioequivalence Study of Divalproex Sodium 125 MG Delayed Release Tablets Under Fasting Conditions | PHASE1 | COMPLETED | 28 | — | — | Oct 1, 2006 | Oct 1, 2006 | Mar 29, 2017 | - | — |
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Divalproex Sodium 125 MG Delayed Release Tablets Sandoz |
| 2 | ACTIVE_COMPARATOR | Depakote 125 MG DR Tablets Abbott Laboratories USA |
| Name | Type | Description |
|---|---|---|
| Divalproex Sodium | DRUG | - |
| Depakote DR Tablets | DRUG | - |
Inclusion Criteria: * No clinically significant findings on physical examination, medical history or laboratory tests on screening Exclusion Criteria: * Positive test for HIV or Hepatitis B and C * History of sensitivity to valproic acid or related compounds