NCT01179646

Bioequivalence Study of Pantoprazole 40 mg DR Tablets and Protonix 40 mg Tablets

A Pharmacokinetic Study to Determine the Bioequivalence of a Test 40 mg Pantoprazole Delayed-Release Tablet, Compared to a Marketed 40 mg Pantoprazole Delayed-Release Tablet (Protonix, Wyeth Pharmaceuticals) When Administered to Healthy Adult Subjects in the Fasted State

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Kremers Urban Development Company · Industry
• Sex: All
• Age: 19 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The objective of this study was to determine the single-dose bioequivalence of the test product, a potential generic 40 mg pantoprazole delayed-release tablet formulation, compared with the reference product, a pantoprazole 40 mg delayed-release tablet formulation (Protonix, Wyeth Pharmaceuticals), following a single dose in the fasted state.

Detailed description

The 90% CI for pantoprazole ln(Cmax), ln\[AUC(0-t)\], and ln\[AUC(0-inf)\] for the comparison of the test product (pantoprazole) versus the reference product (Protonix) should be within the 80 to 125% range required for the conclusion of bioequivalence.

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: 2004-06-01
• Primary completion: 2004-06-01
• Completion: 2004-08-01
• First posted: 2010-08-11
• Last updated: 2010-08-11

Locations

1 site across 1 country: United States