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Mycophenolate Mofetil

Phase 1

Healthy | Small molecule | Other |Dr. Reddy's Laboratories Ltd|Last Updated: Jan 20, 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_CONTROLLEDDMCBiomarker
Total Trials2
Total Enrollment129
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01513044Bioequivalence Study of Mycophenolate Mofetil 250 mg Capsule, Under Fasting ConditionsPHASE1 COMPLETED 68 — — Jan 1, 2009Jan 1, 2009Jan 20, 20121 India
NCT01513057Bioequivalence Study of Mycophenolate Mofetil 250 mg Capsule, Under Fed ConditionsPHASE1 COMPLETED 61 — — Jan 1, 2009Feb 1, 2009Jan 20, 20121 India
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Study Endpoints
Primary Endpoints
Area Under Curve (AUC)
Pre-dose, 0.083, 0.167, 0.25, 0.333, 0.41, 0.50, 0.667, 0.833, 1.00, 1.25, 1.50, 2.00, 2.50, 3.00, 4.00, 5.00, 6.00, 7.00, 8.00, 10.00, 12.00, 16.00, 24.00, 36.00, 48.00, 60.00 and 72.00 post dose
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Mycophenolate MofetilEXPERIMENTALMycophenolate Mofetil 250 mg capsules of Dr. Reddy's Laboratories Limited
CellceptACTIVE_COMPARATORCellcept 250 mg capsules of Roche Laboratories Inc.
Interventions
NameTypeDescription
Mycophenolate MofetilDRUGMycophenolate Mofetil 250 mg capsules of Dr. Reddy's Laboratories Limited
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Eligibility Criteria
Age Range18 Years — 50 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Subjects aged between 18 and 50 years (including both). * Subjects' weight within the normal range according to normal values for the Body * Mass Index (1 8.5 to 24.9 kg/m2) with minimum of 50 kg weight. * Subjects with clinically acceptable normal health as determined by pers...

Countries:India
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