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Lansoprazole

Phase 1

Healthy | Small molecule | Other |Dr. Reddy's Laboratories Ltd|Last Updated: Jan 5, 2011

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment48

FDA Designations

No designations recorded

Clinical trial landscape

Lansoprazole · 1 trial · 1 indication

Phase 1 1
NCT01270308Bioequivalence Study of Lansoprazole DR Capsules 30 mg in Fasting ConditionsHealthy
COMPLETED48 Analytics
PHASE1COMPLETED
Bioequivalence Study of Lansoprazole DR Capsules 30 mg in Fasting Conditions
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Study Endpoints

Primary Endpoints

Bioequivalence based on Cmax and AUC parameters
4 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Lansoprazole DR Capsules 30 mgEXPERIMENTALLansoprazole DR Capsules 30 mg of Dr.Reddy's Laboratories Limited
Prevacid 30 mg CapsulesACTIVE_COMPARATORPrevacid 30 mg Capsules of TAP Pharmaceuticals Inc. USA

Interventions

NameTypeDescription
LansoprazoleDRUGLansoprazole DR Capsules 30 mg
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Eligibility Criteria

Age Range18 Years to 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: i. Provided written informed consent. ii. Subject who were healthy, adult, human beings within 18 and 45 years of age (both inclusive) weighing at least 50 kg. iii. Subject having a body mass index between 18.0 and 29.9 (both inclusive), calculated as weight in Kg/height in m2...

Countries:India
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