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Pepcid

Phase 1

Healthy | Small molecule | Other |Dr. Reddy's Laboratories Ltd|Last Updated: Jan 19, 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_CONTROLLED
Total Trials1
Total Enrollment30
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01511731Bioavailability Study of Famotidine Tablets 40 mg Under Fasting ConditionsPHASE1 COMPLETED 30 — — Oct 1, 1998Oct 1, 1998Jan 19, 20121 Canada
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Study Endpoints
Primary Endpoints
Area Under Curve (AUC)
predose,0. 5, 1, 1. 33, 1. 67, 2, 2. 33, 2.67, 3, 3. 33, 3. 67, 4, 4. 5, 5, 6, 8, 10, 12, 16 and 24 hours post-dose.
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
FamotidineEXPERIMENTALFamotidine tablets 40 mg of Dr. Reddy's
PepcidACTIVE_COMPARATORPepcid 40 mg Tablets of Merck \& Co.,
Interventions
NameTypeDescription
FamotidineDRUGFamotidine Tablets 40 mg
PepcidDRUG40mg tablets
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Eligibility Criteria
Age Range18 Years — 45 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: Exclusion Criteria: History or presence of significant: • cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic or psychiatric disease. In addition, history or presence of: * alcoholism or drug abuse within...

Countries:Canada
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