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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00647712 | Fasting Study of Divalproex Sodium Extended-Release Tablets 500 mg to Depakote ER® Tablets 500 mg | PHASE1 | COMPLETED | 38 | — | — | Dec 1, 2004 | Dec 1, 2004 | Sep 25, 2009 | 1 | United States |
| NCT00648076 | Food Study of Divalproex Sodium Extended-Release Tablets 500 mg to Depakote ER® Tablets 500 mg | PHASE1 | COMPLETED | 40 | — | — | Dec 1, 2004 | Dec 1, 2004 | Sep 25, 2009 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Divalproex Sodium Extended-Release Tablets 500 mg |
| 2 | ACTIVE_COMPARATOR | Depakote ER® Tablets 500 mg |
| Name | Type | Description |
|---|---|---|
| Divalproex Sodium Extended-Release Tablets 500 mg | DRUG | 500mg, single dose fasting |
| Depakote ER® Tablets 500 mg | DRUG | 500mg, single dose fasting |
Inclusion Criteria: 1. Age: 18 years and older. 2. Sex: Male. 3. Weight: At least 60 kg (132 lbs) and within 15% of Ideal Body Weight (IBW), as referenced by the Table of "Desirable Weights of Adults" Metropolitan Life Insurance Company, 1999 (See Part II ADMINISTRATIVE ASPECTS OF BIOEQUIVALENCE PR...