NCT01179659

Bioequivalence Study of Pantoprazole 40 mg DR Tablets and Protonix 40 mg Tablets Under Fed Conditions

A Pharmacokinetic Study to Assess the Bioequivalence of a Single-Dose of KUDCO and Wyeth Pharmaceuticals (Protonix) 40 mg Pantoprazole Sodium Delayed-Release Tablet When Administered to Healthy Adult Volunteers Under Fed Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Kremers Urban Development Company · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The objective of this study was to assess the single-dose bioequivalence of KUDCO's and Wyeth Pharmaceuticals' (Protonix) 40 mg pantoprazole sodium delayed-lease tablets, under fed conditions.

Detailed description

This was an open-label, randomized, fully replicated crossover, 2-sequence bioequivalence study under fed conditions.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Pantoprazole 40 mg DR Tablet vs. Protonix 40 mg DR Tablet	Single dose crossover BE study

Timeline

• Start date: 2005-09-01
• Primary completion: 2005-11-01
• Completion: 2006-03-01
• First posted: 2010-08-11
• Last updated: 2010-08-11

Locations

1 site across 1 country: Canada