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Valganciclovir

Phase 1

Healthy | Small molecule | Other |Dr. Reddy's Laboratories Ltd|Last Updated: Nov 21, 2014

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 Enrollment149
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02296723Bioavailability Study of Valganciclovir Hydrochloride Tablets 450 mg Under Fed ConditionPHASE1 COMPLETED 66 — — Jul 1, 2011Aug 1, 2011Nov 20, 20141 India
NCT02297854Bioavailability Study of Valganciclovir Hydrochloride Tablets 450 mg Under Fasting ConditionPHASE1 COMPLETED 83 — — Jul 1, 2011Aug 1, 2011Nov 21, 20141 India
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Study Endpoints
Primary Endpoints
Area under curve (AUC)
0.00 and at 0.167, 0.333, 0.50, 0.667, 0.833, 1.00, 1.25, 1.50, 1.75, 2.00, 2.333, 2.667, 3.00, 3.333, 3.667, 4.00, 6.00, 8.00, 10.00, 12.00, 16.00 and 24.00 hours post dose
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Valganciclovir Hydrochloride Tablets 450 mgEXPERIMENTALValganciclovir Hydrochloride Tablets 450 mg of Dr. Reddys Laboratories Limited
ValcyteACTIVE_COMPARATORValcyte® 450 mg tablets of Genentech USA Inc., Sanfrancisco
Interventions
NameTypeDescription
Valganciclovir HydrochlorideDRUGValganciclovir Hydrochloride Tablets 450 mg
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy, adult, human volunteers between 18 to 55 years of age (both inclusive) living in and around Ahmedabad city or western part of lndia * Having a Body Mass Index (BMD between 18.5 - 24.9 (both inclusive), calculated as weight in kg / height in meter2 * Not having any sig...

Countries:India
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