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

2014-08-27 03:16:47 | BioPortfolio

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.

Description

All study related procedures, restrictions, duration, dates and timings, information on the study formulation and confidentiality of subject data were explained clearly to the volunteers by clinical personnel at the time of obtaining informed consent. Volunteers who signed the consent form and showed"their willingness to participate in the study were enrolled. Volunteers who satisfied the inclusion and exclusion criteria and found to be healthy on physical examination with laboratory investigation values within reference limits were considered eligible to be admitted into the study.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Healthy

Intervention

Omeprazole

Location

Vimta Labs Limited
Hyderabad
Andhra Pradesh
India
500 051

Status

Completed

Source

Dr. Reddy's Laboratories Limited

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:16:47-0400

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