NCT01283919

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (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 42 (+ 4 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 fasting conditions.42 (+4 standby) healthy, adult, human subjects were enrolled. A single oral dose of40 mg of pantoprazole delayed release tablet will be administered along with 240 mL of drinking water after an overnight fast of at least 10 hours in each period.

Conditions

• Fasting

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