NCT01045642

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

Open Label Balanced Randomized,Two-treatment,Two-period,Two-sequence,Single Dose,Crossover Oral Bioequivalence Study of Omeprazole Mg 20mg DR Capsules With Prilosec OTCTM 20mg in 38 Healthy,Adult,Human Subjects Under Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 38 (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 fasting conditions.

Detailed 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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Omeprazole	Omeprazole Magnesium DR Capsules 20 mg

Timeline

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

Locations

1 site across 1 country: India