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Pantoprazole

Phase 1

FED | Small molecule | Metabolic |Dr. Reddy's Laboratories Ltd|Last Updated: Jan 26, 2011

Target and mechanism

ModalitySmall molecule

Also known as Pantoprazole Sodium

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment52

FDA Designations

No designations recorded

Clinical trial landscape

Pantoprazole · 2 trials · 2 indications

Phase 1 2
NCT01283919Bioequivalence Study of Pantoprazole Sodium DR Tablets 40 mg of Dr. Reddy's Laboratories Limited Under Fasting ConditionFasting
COMPLETED42 Analytics
NCT01283932Bioequivalence Study of Pantoprazole Sodium DR Tablets 40 mg of Dr. Reddy's Laboratories Limited Under Fed ConditionFED
COMPLETED52 Analytics
PHASE1COMPLETED
Bioequivalence Study of Pantoprazole Sodium DR Tablets 40 mg of Dr. Reddy's Laboratories Limited Under Fasting Condition
Fasting
NCT0128391942
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PHASE1COMPLETED
Bioequivalence Study of Pantoprazole Sodium DR Tablets 40 mg of Dr. Reddy's Laboratories Limited Under Fed Condition
FED
NCT0128393252
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Study Endpoints

Primary Endpoints

Bioequivalence on Cmax and AUC parameters
2 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Pantoprazole SodiumEXPERIMENTALPantoprazole Sodium DR Tablets 40 mg of Dr. Reddys Laboratories Limited
ProtonixACTIVE_COMPARATORProtonix 40 mg DR Tablets of Wyeth Laboratories

Interventions

NameTypeDescription
Pantoprazole SodiumDRUGPantoprazole Sodium DR Tablets 40 mg
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Eligibility Criteria

Age Range18 Years to 45 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Subjects will provide written informed consent. 2. Subjects must be healthy human beings within 18-45 years of age (inclusive) weighing at least 50 kg. 3. Subjects must be within ±10% of ideal body weight in relation to height according to Life Insurance Corporation of India ...

Countries:India
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