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Divalproex DR

Phase 1

Epilepsy | Small molecule | Neurology |Novartis AG|Last Updated: Mar 28, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials2
Total Enrollment60

FDA Designations

No designations recorded

Clinical trial landscape

Divalproex DR · 2 trials · 2 indications

Phase 1 2
NCT00913848To Demonstrate the Relative Bioavailability of Divalproex Sodium 500 mg Delayed Release Tablets Under Fed ConditionsEpilepsy
COMPLETED30 Analytics
NCT00913874To Demonstrate the Relative Bioavailability of Divalproex Sodium 500 mg Delayed Release Tablets Under Fasting ConditionsEpilepsy
COMPLETED30 Analytics
PHASE1COMPLETED
To Demonstrate the Relative Bioavailability of Divalproex Sodium 500 mg Delayed Release Tablets Under Fed Conditions
EpilepsyUnlock trial analytics
PHASE1COMPLETED
To Demonstrate the Relative Bioavailability of Divalproex Sodium 500 mg Delayed Release Tablets Under Fasting Conditions
EpilepsyUnlock trial analytics

Study Endpoints

Primary Endpoints

Bioequivalence based on AUC and Cmax
10 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALDivalproex Sodium 500 mg DR Tablets (Sandoz Inc., USA)
2ACTIVE_COMPARATORDepakote 500 mg DR Tablets (Abbott Laboratories, USA)

Interventions

NameTypeDescription
Divalproex Sodium 500 mg DR Tablets (Sandoz Inc., USA)DRUG -
Depakote 500 mg DR Tablets (Abbott Laboratories, USA)DRUG -
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Eligibility Criteria

Age Range21 Years to 47 Years
SexMALE
Healthy VolunteersYes

Inclusion Criteria: * No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening. Exclusion Criteria: * Positive test results for HIV or hepatitis B or C. * Treatment for drug or alcohol dependence.

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