NCT00835588

Pantoprazole Sodium 40 mg DR Tablets Under Fasting Conditions

A Relative Bioavailability Study of Pantoprazole Sodium 40 mg DR Tablets Under Fasting Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 100 (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-release tablets ( manufactured by TEVA Pharmaceuticals Industries, Ltd. and distributed by TEVA Pharmaceuticals USA) with that of PROTONIX® 40 mg delayed-released tablets (Wyeth-Ayerst) in Healthy, adult, non-smoking subjects under 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: 2024-08-20
• Results posted: 2009-08-18

Locations

2 sites across 1 country: United States