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Desipramine Cord Laboratories

Phase 1

Depression | Small molecule | Psychiatry |Novartis AG|Last Updated: Mar 28, 2017

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_CONTROLLED
Total Trials2
Total Enrollment72
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00913809To Demonstrate the Relative Bioequivalency of Cord's 100 mg Desipramine HCL Tablets To Merrell Dow's 100 mg Norpramin TabletsPHASE1 COMPLETED 36Dec 1, 1987Dec 1, 1987Mar 28, 2017 -
NCT00914004To Demonstrate the Relative Bioequivalency of Comparing Single 100 mg Doses Of Cord's 50 mg Desipramine HCL Tablets To Merrell Dow's 50 mg Norpramin TabletsPHASE1 COMPLETED 36 - -Mar 28, 2017 -
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Study Endpoints
Primary Endpoints
Bioequivalence based on AUC and Cmax
24 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTALDesipramine HCL 100 mg Tablets Cord Laboratories
2ACTIVE_COMPARATORNorpramin 100 mg Tablets Merrell Dow Pharmaceuticals, Inc
Interventions
NameTypeDescription
Desipramine HCL 100 mg Tablets Cord LaboratoriesDRUG -
Norpramin 100 mg Tablets Merrell Dow Pharmaceuticals, IncDRUG -
Desipramine HCl 50 mg Tablets Cord LaboratoriesDRUG -
Norpramin 50 mg Tablets Merrell Dow Pharmaceuticals, IncDRUG -
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Eligibility Criteria
Age Range18 Years — 50 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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