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Geneva Clomipramine Under Fasting Conditions

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 Enrollment18

FDA Designations

No designations recorded

Clinical trial landscape

Geneva Clomipramine Under Fasting Conditions · 1 trial · 1 indication

Phase 1 1
NCT00913952To Demonstrate the Relative Bioavailability of Geneva and Basel (Anafranil) 25 mg Clomipramine Hydrochloride Capsules Under Fed and Fasted ConditionsDepression
COMPLETED18 Analytics
PHASE1COMPLETED
To Demonstrate the Relative Bioavailability of Geneva and Basel (Anafranil) 25 mg Clomipramine Hydrochloride Capsules Under Fed and Fasted Conditions
Depression
NCT0091395218
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Study Endpoints

Primary Endpoints

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

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALGeneva 25 mg Clomipramine Hydrochloride Capsules Under Fasting Conditions.
2EXPERIMENTALGeneva 25 mg Clomipramine Hydrochloride Capsules Under Fed Conditions.
3ACTIVE_COMPARATORBasel (Anafranil) 25 mg Clomipramine Hydrochloride Capsules Under Fed Conditions.

Interventions

NameTypeDescription
Geneva 25 mg Clomipramine Hydrochloride Capsules Under Fasting ConditionsDRUG -
Geneva 25 mg Clomipramine Hydrochloride Capsules Under Fed ConditionsDRUG -
Basel (Anafranil) 25 mg Clomipramine Hydrochloride Capsules Under Fed ConditionsDRUG -
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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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