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Bioequivalence Study of Omeprazole Magnesium 20 mg DR Capsule Under Fed 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 fed conditions.

Description

This study used a crossover design consisting of 2 treatments, 2 sequences and 2 periods. Study Period-I and IT were separated by a washout period of 14 days. Use of a crossover design is appropriate since it enables comparison of treatments within the same subject using intrasubject variability thus improving the precision of treatment comparisons. Also use of 14 days of washout period between successive drug administrations eliminates chances of residual drug being present at preceding period (i.e Period 1) to next period (i.e Period II).

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

Wellquest Clinical Research
Mumbai
Maharashtra
India
400 013

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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