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Divalproex

Phase 1

Healthy | Small molecule | Other |Dr. Reddy's Laboratories Ltd|Last Updated: Apr 20, 2012

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedACTIVE_CONTROLLEDDMCBiomarker
Total Trials7
Total Enrollment278
FDA Designations
No designations recorded
Clinical Trials (7)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01581775Bioequivalence Study of Divalproex Sodium ER Tablets 500 mg of Dr. Reddy's Under Fasting ConditionsPHASE1 COMPLETED 54 — — Jan 1, 2011Mar 1, 2011Apr 20, 20121 India
NCT01581788Bioequivalence Study of Divalproex Sodium ER Tablets, 500 mg Under Fed ConditionsPHASE1 COMPLETED 54 — — Jan 1, 2011Mar 1, 2011Apr 20, 20121 India
NCT01132183Bioequivalence Study of Divalproex Sodium Capsules(Sprinkle),125 mg of Dr. Reddy's Under Fasting Condition (Apple Sauce)PHASE1 COMPLETED 34 — — Feb 1, 2007Mar 1, 2007May 27, 20101 India
NCT01055938Bioequivalence Study of Dr. Reddy's Divalproex Sodium Capsules (Sprinkle), 125 mg Under Fasting ConditionsPHASE1 COMPLETED 34 — — Dec 1, 2006Mar 1, 2007Jan 26, 20101 India
NCT01056627Bioequivalence Study of Dr. Reddy's Divalproex Sodium Coated Particles in Capsules, 125 mg, Under Fed ConditionPHASE1 COMPLETED 34 — — Dec 1, 2006Mar 1, 2007Jan 26, 20101 India
NCT01132170Bioequivalency Study of Divalproex Sodium DR Tablets, 500 mg of Dr.Reddy's Under Fasting ConditionsPHASE1 COMPLETED 34 — — Aug 1, 2006Nov 1, 2006Jun 14, 20101 India
NCT01132196Bioequivalence Study of Divalproex Sodium DR Tablets 500 mg of Dr. Reddy's Under Fed ConditionsPHASE1 COMPLETED 34 — — Aug 1, 2006Nov 1, 2006Jun 14, 20101 India
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Study Endpoints
Primary Endpoints
Area under curve (AUC)
Pre-dose 1 hour, 1.50, 3, 4.50, 6, 7.50, 9, 10.50, 12, 13.50, 15, 16.50, 18, 19.50, 21, 22.50, 24, 25.50, 27, 32, 36, 48, 60, 72, 96 hours post-dose.
Bioequivalence based on Cmax and AUC parameters
2 months
Bioequivalence study of Dr.Reddy's Divalproex Sodium Coated Particles in Capsules, 125 mg
4 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Divalproex Sodium ER Tablets, 500 mgEXPERIMENTALDivalproex Sodium ER Tablets, 500 mg of Dr. Reddy's Laboratories Limited
Depakote ER Tablets, 500 mgACTIVE_COMPARATORDepakote ER Tablets, 500 mg of Abbott Laboratories
Divalproex SodiumEXPERIMENTALDivalproex Sodium Coated Particles in Capsules, 125 mg of Dr. Reddy's Laboratories Limited
Depakote SprinkleACTIVE_COMPARATORDepakote Sprinkle 125 mg capsules of Abbott Laboratories, USA
Divalproex Sodium DR Tablets 500 mgEXPERIMENTALDivalproex Sodium DR Tablets 500 mg of Dr. Reddy's Laboratories Limited
Depakote DR 500 mg TabletsACTIVE_COMPARATORDepakote DR 500 mg Tablets of Abbott Laboratories PR Ltd.,
Interventions
NameTypeDescription
Divalproex SodiumDRUGDivalproex Sodium ER Tablets, 500 mg
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Eligibility Criteria
Age Range18 Years — 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

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...

Countries:India
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