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Prilosec

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 Trials1
Total Enrollment44

FDA Designations

No designations recorded

Clinical trial landscape

Prilosec · 1 trial · 1 indication

Phase 1 1
NCT01170169Omeprazole Delayed Release (DR) Capsules Bioequivalence Study of Dr. Reddys Under Fasting ConditionsHealthy
COMPLETED44 Analytics
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
5 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
OmeprazoleEXPERIMENTALOmeprazole Delayed Release Capsules of Dr. Reddy's laboratories limited
PrilosecACTIVE_COMPARATORPrilosec® 40 mg of Merck \& Co.Inc.

Interventions

NameTypeDescription
OmeprazoleDRUGOmeprazole Delayed Release Capsules 40 mg
PrilosecDRUGPrilosec® 40 mg of Merck \& Co.Inc.
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Eligibility Criteria

Age Range18 Years to 45 Years
SexALL
Healthy VolunteersYes

Inclusion Criteria: * Subjects who provided written informed consent. * Subjects who were healthy within 18-45 years of age, weighing at least 50 kg. * Body mass index of ≥ 18 kglm2 and ≤ 25 kg/m2, with body weight not less than 50 kg. * Subjects with normal health as determined by medical history ...

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Frequently asked questions about Prilosec

What is Prilosec used for?

Prilosec is a small molecule drug being studied in healthy volunteers. The completed clinical trial for Prilosec was a bioequivalence study of omeprazole delayed release capsules under fasting conditions. The drug is being developed by Dr. Reddy's Laboratories Ltd for use in healthy individuals.

Who makes Prilosec?

Prilosec is being developed by Dr. Reddy's Laboratories Ltd, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol RDY. The company conducted a Phase 1 bioequivalence study of the drug in healthy volunteers.

What phase is Prilosec in?

Prilosec is in Phase 1 clinical development. The drug is investigational and has not been approved by regulatory authorities. One Phase 1 trial has been completed, and there are no active trials currently ongoing for Prilosec.

What clinical trials is Prilosec in?

Prilosec has one completed clinical trial registered under NCT01170169. This Phase 1 study was a bioequivalence trial of omeprazole delayed release capsules conducted under fasting conditions. The trial enrolled 44 healthy participants aged 18 years and older.

Is Prilosec the same as omeprazole?

Prilosec is a brand name for the drug omeprazole. The clinical trial for Prilosec studied omeprazole delayed release capsules. The study was designed to compare the bioequivalence of Dr. Reddy's formulation of omeprazole under fasting conditions.