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Risperidone

Phase 1

Healthy | Small molecule | Other |Dr. Reddy's Laboratories Ltd|Last Updated: Feb 8, 2010

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials2
Total Enrollment56

FDA Designations

No designations recorded

Clinical trial landscape

Risperidone · 2 trials · 1 indication

Phase 1 2
NCT01064232Risperidone Tablets, 1 mg Bioequivalence Study of Dr.Reddy's Under Fasting ConditionHealthy
COMPLETED30 Analytics
NCT01064271Risperidone Tablets, 1 mg Bioequivalence Study of Dr.Reddy's Under Fed ConditionHealthy
COMPLETED26 Analytics
PHASE1COMPLETED
Risperidone Tablets, 1 mg Bioequivalence Study of Dr.Reddy's Under Fasting Condition
Healthy
NCT0106423230
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PHASE1COMPLETED
Risperidone Tablets, 1 mg Bioequivalence Study of Dr.Reddy's Under Fed Condition
Healthy
NCT0106427126
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Study Endpoints

Primary Endpoints

Bio-equivalence study of Dr Reddys Laboratories Risperidone Tablets 1 mg
3-4 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
RisperidoneEXPERIMENTALRisperidone Tablets 1 mg of Dr Reddys Laboratories Limited
RisperdalACTIVE_COMPARATORRisperdal® Tablets, 1 mg of Janssen Pharmaceutica Products, L.P
Risperdal®ACTIVE_COMPARATORRisperdal® Tablets, 1 mg of Janssen Pharmaceutica Products, L.P

Interventions

NameTypeDescription
RisperidoneDRUGRisperidone Tablets 1 mg
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes

Inclusion Criteria: 1. Males and females, 18 - 55 years of age. 2. Female subjects of child bearing potential must either abstain from sexual intercourse or use a reliable method of contraception (e.g. condom with spermicide, IUD, hormonal contraceptives) for at least 30 days prior to dosing and du...

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