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Famotidine

Phase 1

Healthy | Small molecule | Other |Dr. Reddy's Laboratories Ltd|Last Updated: Jan 19, 2012

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment30

FDA Designations

No designations recorded

Clinical trial landscape

Famotidine · 1 trial · 1 indication

Phase 1 1
NCT01511731Bioavailability Study of Famotidine Tablets 40 mg Under Fasting ConditionsHealthy
COMPLETED30 Analytics
PHASE1COMPLETED
Bioavailability Study of Famotidine Tablets 40 mg Under Fasting Conditions
Healthy
NCT0151173130
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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 to 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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