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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.
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).
Allocation: Randomized, Control: Active Control, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Wellquest Clinical Research
Dr. Reddy's Laboratories Limited
Published on BioPortfolio: 2014-08-27T03:16:47-0400
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The S-isomer of omeprazole.
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