Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Divalproex · 7 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| Divalproex Sodium ER Tablets, 500 mg | EXPERIMENTAL | Divalproex Sodium ER Tablets, 500 mg of Dr. Reddy's Laboratories Limited |
| Depakote ER Tablets, 500 mg | ACTIVE_COMPARATOR | Depakote ER Tablets, 500 mg of Abbott Laboratories |
| Divalproex Sodium | EXPERIMENTAL | Divalproex Sodium Coated Particles in Capsules, 125 mg of Dr. Reddy's Laboratories Limited |
| Depakote Sprinkle | ACTIVE_COMPARATOR | Depakote Sprinkle 125 mg capsules of Abbott Laboratories, USA |
| Divalproex Sodium DR Tablets 500 mg | EXPERIMENTAL | Divalproex Sodium DR Tablets 500 mg of Dr. Reddy's Laboratories Limited |
| Depakote DR 500 mg Tablets | ACTIVE_COMPARATOR | Depakote DR 500 mg Tablets of Abbott Laboratories PR Ltd., |
| Name | Type | Description |
|---|---|---|
| Divalproex Sodium | DRUG | Divalproex Sodium ER Tablets, 500 mg |
Inclusion Criteria: The subjects were selected for study participation, if they met the following criteria: 1. Subjects aged between 18 and 45 years (both inclusive). 2. Subjects' weight within normal range according to normal values for Body Mass Index (18.5 to 24.9 kg/m2) with minimum of 50 kg w...
Divalproex is a small molecule drug being developed by Dr. Reddy's Laboratories Ltd (RDY). It is currently in Phase 1 clinical development, with studies conducted in healthy volunteers. The drug is being studied in bioequivalence trials for tablet formulations.
Divalproex is being studied in healthy volunteers for bioequivalence purposes. The clinical trials are designed to compare the pharmacokinetics of Dr. Reddy's divalproex sodium tablets against reference products under fasting and fed conditions. It is not being studied for a specific disease indication in these trials.
Divalproex is developed by Dr. Reddy's Laboratories Ltd, a pharmaceutical company listed on the stock exchange under the ticker RDY. The company is conducting Phase 1 bioequivalence studies for divalproex sodium tablets in healthy volunteers.
Divalproex is in Phase 1 clinical development. All seven clinical trials listed for the drug are Phase 1 studies, and all have been completed. The drug is investigational and has not been approved by regulatory authorities based on the available trial data.
Divalproex has been studied in seven completed Phase 1 trials, including NCT01132170, NCT01132196, NCT01581775, and NCT01581788. These trials assessed bioequivalence of divalproex sodium delayed-release and extended-release tablets under fasting and fed conditions in healthy volunteers in India.
Divalproex is the drug name used in the clinical trials, and the studies specifically evaluate divalproex sodium tablets. The trials refer to divalproex sodium DR (delayed-release) and ER (extended-release) tablets, indicating that Divalproex refers to the sodium salt form of the drug.