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Zonisamide

Phase 1

Healthy | Small molecule | Other |Dr. Reddy's Laboratories Ltd|Last Updated: Jul 14, 2010

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_CONTROLLEDBiomarker
Total Trials2
Total Enrollment52
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01161966Bioequivalence Study of Zonisamide Capsules 100 mg of Dr.Reddy's Laboratories Limited Under Fasting ConditionsPHASE1 COMPLETED 26Jan 1, 2005Mar 1, 2005Jul 14, 20101 United States
NCT01161979Bioequivalence Study of Zonisamide Capsules 100 mg of Dr.Reddy's Laboratories Limited Under Fed ConditionsPHASE1 COMPLETED 26Jan 1, 2005Mar 1, 2005Jul 14, 20101 United States
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Study Endpoints
Primary Endpoints
Bioequivalence on Cmax,AUC and Tmax Parameters
3 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ZonisamideEXPERIMENTALZonisamide Capsules 100 mg of Dr.Reddy's laboratories Limited
ZonegranACTIVE_COMPARATORZonegran Capsules 100 mg of EISAI INC
Interventions
NameTypeDescription
ZonisamideDRUGZonisamide capsules 100 mg
ZonegranDRUGZonegran Capsules 100 mg of EISAI INC
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Is the individual a healthy, normal adult man or non-child bearing potential woman who volunteers to participate? * Is s/he at least 18 years of age? * Is his/her BMI between 19 and 30, inclusive? * Is s/he considered reliable and capable of understanding his/her responsibilit...

Countries:United States
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