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Clomipramine

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 Enrollment36

FDA Designations

No designations recorded

Clinical trial landscape

Clomipramine · 1 trial · 1 indication

Phase 1 1
NCT00913783To Demonstrate the Relative Bioavailability of Geneva and Basel (Anafranil) 25 mg Clomipramine Hydrochloride Capsules Under Fasted ConditionsDepression
COMPLETED36 Analytics
PHASE1COMPLETED
To Demonstrate the Relative Bioavailability of Geneva and Basel (Anafranil) 25 mg Clomipramine Hydrochloride Capsules Under Fasted Conditions
Depression
NCT0091378336
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Study Endpoints

Primary Endpoints

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

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALClomipramine Hydrochloride 25 mg Capsules (Geneva Pharmaceuticals)
2ACTIVE_COMPARATORAnafranil Clomipramine Hydrochloride 25 mg Capsules (Basel)

Interventions

NameTypeDescription
Clomipramine Hydrochloride 25 mg Capsules (Geneva Pharmaceuticals)DRUG -
Anafranil Clomipramine Hydrochloride 25 mg Capsules (Basel)DRUG -
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Eligibility Criteria

Age Range18 Years to 45 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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