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Divalproex · 2 trials · 1 indication
| 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...
Divalproex is a small molecule drug being developed by Viatris Inc. (VTRS). It is currently in Phase 1 clinical development. The available clinical trials for Divalproex are conducted in healthy volunteers, and the drug is being studied for its pharmacokinetic profile, specifically in fasting and fed conditions.
Divalproex is being developed by Viatris Inc., a global healthcare company. Viatris is publicly traded under the ticker symbol VTRS on the NASDAQ stock exchange. The company is conducting Phase 1 clinical trials to evaluate the drug's pharmacokinetics in healthy subjects.
Divalproex is currently in Phase 1 clinical development. Two Phase 1 trials have been completed, both involving healthy volunteers. These trials were designed to assess the pharmacokinetics of Divalproex sodium extended-release tablets compared to a reference product. The drug is investigational and not yet approved for any indication.
Divalproex has two completed Phase 1 clinical trials. NCT00647712 is a fasting study comparing Divalproex sodium extended-release tablets 500 mg to Depakote ER tablets 500 mg, with 38 male participants. NCT00648076 is a food study with the same comparison, enrolling 40 male participants. Both trials were conducted in the United States.
Divalproex sodium is the active ingredient in Depakote ER tablets. The clinical trials for Divalproex compare the generic formulation to the brand-name Depakote ER to assess bioequivalence. The trials are designed to evaluate whether Divalproex sodium extended-release tablets are equivalent to Depakote ER in healthy volunteers.