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Rivastigmine

Phase 1

Healthy | Small molecule | Other |Dr. Reddy's Laboratories Ltd|Last Updated: Jan 13, 2012

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials2
Total Enrollment88
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01146041Bioequivalence Study of Rivastigmine Capsules 1.5 mg of Dr.Reddy's Under Fed ConditionsPHASE1 COMPLETED 44Feb 1, 2004Apr 1, 2004Jun 17, 2010 -
NCT01146067Bioequivalence Study of Rivastigmine 1.5 mg Capsules Under Fasting ConditionsPHASE1 COMPLETED 44Jan 1, 2004Feb 1, 2004Jan 13, 2012 -
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Study Endpoints
Primary Endpoints
Bioequivalence based on Cmax and AUC parameters
3 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
RivastigmineEXPERIMENTALRivastigmine capsules 1.5 mg of Dr.Reddy's Laboratories Limited
exelonACTIVE_COMPARATORExelon 1.5 mg capsules of Novartis
Interventions
NameTypeDescription
RivastigmineDRUGRivastigmine 1.5 mg Capsules
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersYes

Inclusion criteria * Subjects enrolled in this study will be members of the community at large. The recruitment advertisements may use various media types (e.g. radio, newspaper, Anapharm Inc. Web site, Anapharm Inc. volunteer's database). Subjects must meet all of the following criteria in order t...

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