Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Divalproex · 4 trials · 1 indication
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...
Divalproex is a small molecule drug being developed by Teva Pharmaceutical Industries Limited (TEVA). In the clinical trials listed, it is studied in healthy volunteers, so the indication is Healthy. It is currently in Phase 1 clinical development, with all trials completed.
Divalproex is developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. The company is conducting Phase 1 clinical trials of the drug in healthy volunteers in the United States.
Divalproex is in Phase 1 clinical development. All four clinical trials listed are Phase 1 studies, and they have all been completed. The drug is investigational and not yet approved for any use.
Divalproex has four completed Phase 1 trials: NCT00834639 and NCT00834990 study Divalproex Sodium Delayed-Release Tablets under fasting and non-fasting conditions, respectively. NCT00974012 and NCT00974441 study Divalproex Sodium 500 mg Extended Release Tablets under non-fasting and fasting conditions. All enrolled healthy adults in the United States.
The clinical trials for Divalproex use the name Divalproex Sodium in their titles, indicating that Divalproex refers to the sodium salt form of the drug. The trials study both delayed-release and extended-release tablet formulations of Divalproex Sodium.