NCT00835393

Pantoprazole Sodium 40 mg DR Tablets Under Non-Fasting Conditions

A Relative Bioavailability Replicated Crossover Study of Pantoprazole Sodium 40 mg DR Tablets Under Non-Fasting Conditions.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Teva Pharmaceuticals USA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The Objective of this study is to compare the relative bioavailability of pantoprazole sodium 40 mg delayed-released tablets (manufactured by TEVA Pharmaceutical Industries,Ltd. and distributed by TEVA Pharmaceuticals USA)with that of PROTONIX® 40mg delayed-released tablets (Wyeth- Ayerst) in Healthy, adult, non-smoking subjects under non- fasting conditions.

Detailed description

Criteria for Evaluation: FDA Bioequivalence Criteria Statistical Methods: FDA bioequivalence statistical methods

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Pantoprazole Sodium 40 mg delayed-release tablets	1 x 40 mg
DRUG	PROTONIX® 40 mg delayed-release tablets.	1 x 40 mg

Timeline

• Start date: 2003-12-01
• Primary completion: 2003-12-01
• Completion: 2003-12-01
• First posted: 2009-02-03
• Last updated: 2009-02-03

Locations

2 sites across 1 country: United States