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Desipramine Cord Laboratories

Phase 1

Depression | Small molecule | Psychiatry |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 Enrollment72

FDA Designations

No designations recorded

Clinical trial landscape

Desipramine Cord Laboratories · 2 trials · 1 indication

Phase 1 2
NCT00913809To Demonstrate the Relative Bioequivalency of Cord's 100 mg Desipramine HCL Tablets To Merrell Dow's 100 mg Norpramin TabletsDepression
COMPLETED36 Analytics
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 TabletsDepression
COMPLETED36 Analytics
PHASE1COMPLETED
To Demonstrate the Relative Bioequivalency of Cord's 100 mg Desipramine HCL Tablets To Merrell Dow's 100 mg Norpramin Tablets
Depression
NCT0091380936
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PHASE1COMPLETED
To 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 Tablets
Depression
NCT0091400436
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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 to 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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Frequently asked questions about Desipramine Cord Laboratories

What is Desipramine Cord Laboratories used for?

Desipramine Cord Laboratories is an investigational small molecule being studied for the treatment of depression. It is in Phase 1 clinical development and is not yet approved by the FDA. The drug is being evaluated in healthy volunteers to assess its bioequivalence to reference products.

Who makes Desipramine Cord Laboratories?

Desipramine Cord Laboratories is being developed by Novartis AG, which trades on the New York Stock Exchange under the ticker NVS. The drug is currently in Phase 1 clinical development for depression.

What phase is Desipramine Cord Laboratories in?

Desipramine Cord Laboratories is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. Two Phase 1 trials have been completed, both involving healthy male volunteers.

What clinical trials is Desipramine Cord Laboratories in?

Desipramine Cord Laboratories has two completed Phase 1 trials: NCT00913809 and NCT00914004. Both studies evaluated the bioequivalence of desipramine hydrochloride tablets compared to reference Norpramin tablets in healthy male volunteers aged 18 years and older. Each trial enrolled 36 participants.

Is Desipramine Cord Laboratories the same as Norpramin?

Desipramine Cord Laboratories is not the same as Norpramin. It is a generic version of desipramine hydrochloride being tested for bioequivalence to Norpramin, which is the reference product. The clinical trials compare the two to demonstrate that the generic formulation is equivalent.