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Risperidone

Phase 1

Healthy | Small molecule | Other |Teva Pharmaceutical Industries Limited|Last Updated: Aug 19, 2024

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials2
Total Enrollment54

FDA Designations

No designations recorded

Clinical trial landscape

Risperidone · 2 trials · 1 indication

Phase 1 2
NCT00829894Risperidone 1 mg Tablets Dosed in Healthy Subjects Under Fed ConditionsHealthy
COMPLETED24 Analytics
NCT00830349Risperidone 1 mg Tablet in Healthy Subjects Under Fasting ConditionsHealthy
COMPLETED30 Analytics
PHASE1COMPLETED
Risperidone 1 mg Tablets Dosed in Healthy Subjects Under Fed Conditions
Healthy
NCT0082989424
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PHASE1COMPLETED
Risperidone 1 mg Tablet in Healthy Subjects Under Fasting Conditions
Healthy
NCT0083034930
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Study Endpoints

Primary Endpoints

Bioequivalence based on Cmax and AUC
2 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
1EXPERIMENTALRisperidone 1 mg Tablet
2ACTIVE_COMPARATORRisperdal® 1 mg Tablet

Interventions

NameTypeDescription
RisperidoneDRUG1 mg Tablet
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria * Subjects will be females and/or males, non-smokers, 18 years of age and older. * Subjects should read, sign and date an Informed Consent Form prior to any study procedure. * Female Subjects will be post-menopausal or surgically sterilezed. * Post-menopausal status is defined as...

Countries:Canada
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