Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
DEPAKOTE · 2 trials · 1 indication
Maximum plasma concentration (micrograms/mL)
Area under the concentration time curve from time zero to the last measurable time point. (micrograms x mL/hour)
Area under the concentration time curve from time zero to infinity (micrograms x mL/hour)
| Arm | Type | Description |
|---|---|---|
| Divalproex Sodium | EXPERIMENTAL | DIVALPROEX SODIUM DELAYED-RELEASE TABLETS, USP, 500 MG - Mylan Pharmaceuticals Inc |
| Depakote Tablets | ACTIVE_COMPARATOR | DEPAKOTE® Tablets, 500 MG Abbott Laboratories |
| Test: Divalproex Sodium | EXPERIMENTAL | DIVALPROEX SODIUM DELAYED-RELEASE TABLETS, USP, 500 MG |
| Reference: Depakote Tablets | ACTIVE_COMPARATOR | DEPAKOTE® Tablets, 500 MG Abbott Laboratories |
| Name | Type | Description |
|---|---|---|
| DEPAKOTE® Tablets, 500 MG | DRUG | 1 x 500 mg Tablet, under fed conditions |
| DIVALPROEX SODIUM DELAYED-RELEASE TABLETS, USP, 500 MG | DRUG | 1 x 500 mg Tablet, under fed conditions |
Inclusion Criteria: 1. Age: 18 years and older. 2. Sex: Females not of child bearing potential and males. * No hormonal contraceptives or hormonal replacement therapies are permitted in this study. * Women will not be considered of childbearing potential if one of the following is reported a...
DEPAKOTE is a small molecule drug being studied in healthy volunteers. It is currently in Phase 1 clinical development, with two completed bioequivalence studies. The drug is being developed by Viatris Inc. and is not yet approved for any indication.
DEPAKOTE is developed by Viatris Inc., a company traded on the NASDAQ under the ticker VTRS. The drug is currently in Phase 1 clinical trials, with two completed studies in healthy volunteers.
DEPAKOTE is in Phase 1 clinical development. It has completed two Phase 1 bioequivalence studies in healthy volunteers. The drug is investigational and has not been approved by regulatory authorities.
DEPAKOTE has two completed Phase 1 clinical trials: NCT01183676, a fed bioequivalence study of divalproex sodium delayed-release tablets 500 mg with 20 participants, and NCT01184391, a bioequivalence study of the same tablet with 17 participants. Both were conducted in the United States.
DEPAKOTE is the brand name for divalproex sodium delayed-release tablets. The clinical trials for DEPAKOTE specifically study divalproex sodium delayed-release tablets at a 500 mg dose, confirming that DEPAKOTE and divalproex sodium refer to the same drug substance.