Study Comparing 2 Different Formulations of Pantoprazole in Healthy Adults.

Phase 1

Completed

• Conditions: Healthy Subjects

• Registration Number: NCT00383916
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

A study comparing 2 different investigational formulations of pantoprazole in healthy adults.

Detailed Description

open-label, single-dose, randomized, 2-period, 2-sequence, crossover, inpatient bioequivalence study

Study Timeline

• Study Start: 2006-10
• Study Completion: 2006-10
• Study First Submitted: 2006-10-02
• Study First Submitted QC: 2006-10-02
• Study First Posted: 2006-10-04
• Status Verified: 2007-03
• Last Update Submitted: 2007-03-07
• Last Update Posted: 2007-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
To determine the bioequivalence of the Altana formulation of pantoprazole to the Wyeth formulation of pantoprazole delayed-release granules.

Secondary Outcome Measures

Name	Time	Method
To obtain additional safety and tolerability data concerning pantoprazole in healthy subjects and to assess the pharmacokinetics of the Altana formulation.