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Ranitidine

Phase 1

Healthy | Small molecule | Other |Dr. Reddy's Laboratories Ltd|Last Updated: Jun 9, 2010

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 Trials1
Total Enrollment24
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01131702Bioequivalency Study of Ranitidine Tablets 300 mg of Dr. Reddy's Under Fasting ConditionsPHASE1 COMPLETED 24Jan 1, 2003Mar 1, 2003Jun 9, 20101 Canada
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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
Ranitidine Tablets, 300 mgEXPERIMENTALRanitidine Tablets, 300 mg of Dr. Reddy's Laboratories Limited
Zantac Tablets, 300 mgACTIVE_COMPARATOR -
Interventions
NameTypeDescription
RanitidineDRUGRanitidine Tablets, 300 mg
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Subjects enrolled in this study will be members of the community at large. The recruitment advertisements may be done using different media (e.g. radio, newspaper, Anapharm Inc. Web site. Anapharm Inc. volunteers' data base). Subjects must meet all of the following criteria in...

Countries:Canada
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