NCT01170182

Omeprazole Delayed Release (DR) Capsules Bioequivalence Study of Dr. Reddys Under Fed Condition

A Randomized, Two-treatment, Two-period, Two-sequence, Single Dose, Crossover Bioequivalence Study to Compare Omeprazole 40 mg DR Capsules Dr. Reddy's Laboratories Ltd.,With Prilosec® 40 mg Merck & Co., Inc.,USA Under Fed Condition

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Dr. Reddy's Laboratories Limited · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This study examines the bioequivalence of Dr. Reddy's Omeprazole delayed release capsules under fed condition.

Detailed description

This is a randomized, two-treatment, two-period, two-sequence, single dose, crossover bioequivalence study to compare Omeprazole 40 mg Delayed Release Capsules (Dr. Reddy's Laboratories Ltd.,) with Prilosec® 40 mg (Omeprazole Delayed Release Capsules) (manufactured by Merck \& Co., Inc., USA) in 54 healthy, adult, human subjects under fed conditions.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Omeprazole	Omeprazole Delayed Release Capsules 40 mg
DEVICE	Prilosec® 40 mg	Prilosec® 40 mg

Timeline

• Start date: 2006-02-01
• Primary completion: 2006-04-01
• Completion: 2006-04-01
• First posted: 2010-07-27
• Last updated: 2010-07-27