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Ziprasidone

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
RandomizedCONTROLLEDDMCBiomarker
Total Trials2
Total Enrollment94
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01581866Bioequivalence Study of Ziprasidone HCL Capsules, 20 mg Under Fasting ConditionsPHASE1 COMPLETED 56Nov 1, 2004Jan 1, 2005Apr 20, 20121 United States
NCT01581879Bioequivalence Study of Ziprasidone HCL Capsules, 20 mg of Dr. Reddy's Under Fed ConditionsPHASE1 COMPLETED 38Nov 1, 2004Jan 1, 2005Apr 20, 20121 United States
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Study Endpoints
Primary Endpoints
Area under curve (AUC)
1, 2, 3, 3.50, 4, 4.50, 5, 5.50, 6, 6.50, 7, 8, 9, 10, 12, 16, 24 and 36 hours post-dose
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Ziprasidone HCL Capsules, 20 mgEXPERIMENTALZiprasidone HCL Capsules, 20 mg of Dr. Reddy's Laboratories Limited
Geodon Capsules, 20 mgEXPERIMENTALGeodon Capsules, 20 mg of Pfizer Inc
Interventions
NameTypeDescription
Ziprasidone HydrochlorideDRUGZiprasidone HCL Capsules, 20 mg
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Eligibility Criteria
Age Range18 Years — 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Male or female, smoker or non-smoker, 18 years of age and older. * Capable of consent. * BMI between 19.0 and 30.0 kg/m2 inclusively. Exclusion Criteria: * Clinically significant illnesses within 4 weeks prior to the administration of the study medication. * Clinically signi...

Countries:United States
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