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Imipramine

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 Trials1
Total Enrollment48

FDA Designations

No designations recorded

Clinical trial landscape

Imipramine · 1 trial · 1 indication

Phase 1 1
NCT00946764To Demonstrate the Relative Bioavailability of Sandoz Inc. and Tyco Healthcare (Tofranil) 50 mg Imipramine Hydrochloride Tablets In Healthy Adults Volunteers Under Fasting ConditionsDepression
COMPLETED48 Analytics
PHASE1COMPLETED
To Demonstrate the Relative Bioavailability of Sandoz Inc. and Tyco Healthcare (Tofranil) 50 mg Imipramine Hydrochloride Tablets In Healthy Adults Volunteers Under Fasting Conditions
Depression
NCT0094676448
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Study Endpoints

Primary Endpoints

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

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALImipramine Hydrochloride 50 mg Tablets (Sandoz Inc.)
2ACTIVE_COMPARATORTofranil Imipramine Hydrochloride 50 mg Tablets (Tyco Healthcare)

Interventions

NameTypeDescription
Imipramine Hydrochloride 50 mg Tablets (Sandoz Inc.)DRUG -
Tofranil Imipramine Hydrochloride 50 mg Tablets (Tyco Healthcare)DRUG -
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Eligibility Criteria

Age Range19 Years to 54 Years
SexALL
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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