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Omeprazole

Phase 1

Healthy | Small molecule | Other |Dr. Reddy's Laboratories Ltd|Last Updated: Jul 27, 2010

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials4
Total Enrollment198

FDA Designations

No designations recorded

Clinical trial landscape

Omeprazole · 4 trials · 1 indication

Phase 1 4
NCT01045434Bioequivalence Study of Omeprazole Magnesium 20 mg DR Capsule Under Fed ConditionsHealthy
COMPLETED62 Analytics
NCT01045642Bioequivalence Study of Omeprazole Magnesium 20 mg DR Capsules Under Fasting ConditionsHealthy
COMPLETED38 Analytics
NCT01170182Omeprazole Delayed Release (DR) Capsules Bioequivalence Study of Dr. Reddys Under Fed ConditionHealthy
COMPLETED54 Analytics
NCT01170169Omeprazole Delayed Release (DR) Capsules Bioequivalence Study of Dr. Reddys Under Fasting ConditionsHealthy
COMPLETED44 Analytics
PHASE1COMPLETED
Bioequivalence Study of Omeprazole Magnesium 20 mg DR Capsule Under Fed Conditions
Healthy
NCT0104543462
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PHASE1COMPLETED
Bioequivalence Study of Omeprazole Magnesium 20 mg DR Capsules Under Fasting Conditions
Healthy
NCT0104564238
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PHASE1COMPLETED
Omeprazole Delayed Release (DR) Capsules Bioequivalence Study of Dr. Reddys Under Fed Condition
Healthy
NCT0117018254
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PHASE1COMPLETED
Omeprazole Delayed Release (DR) Capsules Bioequivalence Study of Dr. Reddys Under Fasting Conditions
Healthy
NCT0117016944
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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
Omeprazole Magnesium DR 20 mg CapsulesEXPERIMENTALOmeprazole Magnesium DR 20 mg Capsules of Dr Reddys Laboratories Limited
Prilosec 20 mg TabletsACTIVE_COMPARATORPrilosec 20 mg Tablets of Procter and Gamble
OmeprazoleEXPERIMENTALOmeprazole Delayed Release Capsules of Dr. Reddy's Laboratories Limited
PrilosecACTIVE_COMPARATORPrilosec® 40 mg Merck \& Co. Inc

Interventions

NameTypeDescription
OmeprazoleDRUGOmeprazole Magnesium DR 20 mg Capsules
Prilosec® 40 mgDEVICEPrilosec® 40 mg
PrilosecDRUGPrilosec® 40 mg of Merck \& Co.Inc.
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Eligibility Criteria

Age Range18 Years to 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy human subjects within the age range of 18 to 45 years. * Non-smokers since at least six months. * Willingness to provide written informed consent to participate in the study. * Body-mass index of ≥18.5 kg/m2 and≤ 24.9 kglm2, with body weight not less than 50 kg. * Abse...

Countries:India
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