NCT01045434

Bioequivalence Study of Omeprazole Magnesium 20 mg DR Capsule Under Fed Conditions

Open Label, Balanced, Randomized, Two-treatment,Two-period,Single-dose, Cross-over Oral Bioequivalence Study of Omeprazole Magnesium 20 mg DR Capsule With Prilosec® OTCTM 20 mg Tablets in Healthy Human Adult Subjects, Under Fed Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Dr. Reddy's Laboratories Limited · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed 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).

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Omeprazole	Omeprazole Magnesium DR 20 mg Capsules

Timeline

• Start date: 2006-12-01
• Primary completion: 2007-01-01
• Completion: 2007-03-01
• First posted: 2010-01-11
• Last updated: 2010-01-20

Locations

1 site across 1 country: India