NCT01283932

Bioequivalence Study of Pantoprazole Sodium DR Tablets 40 mg of Dr. Reddy's Laboratories Limited Under Fed Condition

A Randomized, Two-treatment, Two-period, Two-sequence,Single Dose, Crossover Bioequivalence Study of Pantoprazole Sodium 40 mg Delayed Release Tablets (Dr. Reddy's Laboratories Ltd, India) to be Compared With Protonix® 40 mg (Pantoprazole Sodium) Delayed Release Tablets (Wyeth Laboratories, USA) in Healthy, Adult, Human Subjects Under Fed Conditions.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Dr. Reddy's Laboratories Limited · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

To compare the single dose bioavailability of pantoprazole sodium 40 mg delayed release tablets (Dr. Reddy's Laboratories Ltd, India) with Protonix® 40 mg delayed release tablets (Wyeth Laboratories, USA) in 52 (+ 6 standby) healthy, adult, human subjects under fasting conditions.

Detailed description

This is a Open label, balanced, randomized two-treatment, two-period,two-sequence, crossover bioequivalence study with at least 07 days washout period between each drug administration under fed conditions.52 (+6 standby) healthy, adult, human subjects were enrolled. A single oral dose of 40 mg of pantoprazole delayed release tablet will be administered along with 240 mL of drinking water within 30 minutes after serving a high fat breakfast.

Conditions

• FED

Interventions

Type	Name	Description
DRUG	Pantoprazole Sodium	Pantoprazole Sodium DR Tablets 40 mg

Timeline

• Start date: 2004-10-01
• Primary completion: 2004-12-01
• Completion: 2004-12-01
• First posted: 2011-01-26
• Last updated: 2011-01-26

Locations

1 site across 1 country: India