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Bioequivalence Study of Omeprazole Magnesium 20 mg DR Capsules Under Fasting Conditions

NCT01045642 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2010-01-20

No results posted yet for this study

Summary

An open label, balanced, randomized, two-treatment, two-period, two-sequence, single dose, crossover oral bioequivalence study of Omeprazole Magnesium 20 mg DR Capsules of Dr. Reddy's Laboratories Limited, India and Prilosec OTCTM 20 mg (Omeprazole Magnesium DR Tablets) of Procter and Gamble, Cincinnati, Sweden in 38 healthy, adult, human subjects under fasting conditions.

Conditions

  • Healthy

Interventions

DRUG

Omeprazole

Omeprazole Magnesium DR Capsules 20 mg

Sponsors & Collaborators

  • Dr. Reddy's Laboratories Limited

    lead INDUSTRY

Principal Investigators

  • Dr IS Gandhi · Vimta Labs Limited

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-12-31
Primary Completion
2006-12-31
Completion
2007-03-31

Countries

  • India

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01045642 on ClinicalTrials.gov