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Desipramine

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 · 2 trials · 1 indication

Phase 1 2
NCT00913822To Demonstrate the Relative Bioavailability of Desipramine Hydrochloride TabletsDepression
COMPLETED36 Analytics
NCT00913237To Demonstrate the Relative Bioavailability of Desipramine Hydrochloride 50 mg TabletsDepression
COMPLETED36 Analytics
PHASE1COMPLETED
To Demonstrate the Relative Bioavailability of Desipramine Hydrochloride Tablets
DepressionUnlock trial analytics
PHASE1COMPLETED
To Demonstrate the Relative Bioavailability of Desipramine Hydrochloride 50 mg Tablets
DepressionUnlock trial analytics

Study Endpoints

Primary Endpoints

Bioequivalence based on AUC and Cmax
22 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALDesipramine Hydrochloride 100 mg Tablets (Cord Laboratories)
2ACTIVE_COMPARATORNorpramin 100 mg Tablets (Merrell Dow Pharmaceuticals, Inc.)

Interventions

NameTypeDescription
Desipramine Hydrochloride 100 mg Tablets (Cord Laboratories)DRUG -
Norpramin 100 mg Tablets (Merrell Dow Pharmaceuticals, Inc.)DRUG -
Desipramine Hydrochloride 50 mg Tablets (Cord Laboratories)DRUG -
Desipramine Hydrochloride 50 mg Tablets (Merrell Dow Pharmaceuticals, Inc)DRUG -
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Eligibility Criteria

Age Range18 Years to 40 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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