Study Comparing 2 Different Formulations of Pantoprazole in Healthy Adults.

This study has been completed.

First Received: October 2, 2006 Last Updated: March 7, 2007 History of Changes

Sponsor:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00383916

Purpose

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

Condition	Intervention	Phase
Healthy Subjects	Drug: pantoprazole	Phase I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Crossover Assignment, Bio-equivalence Study
Official Title:	An Open-Label, Single-Dose, Randomized, 2-Period, Crossover, Bioequivalence Study Between the Altana Formulation of Pantoprazole Delayed-Release Granules and the Wyeth Formulation of Pantoprazole Delayed-Release Granules in Healthy Subjects.

Resource links provided by NLM:

Drug Information available for: Pantoprazole Pantoprazole Sodium

Further study details as provided by Wyeth:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Study Start Date:	October 2006
Estimated Study Completion Date:	October 2006

Detailed Description:

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

Eligibility

Criteria

Inclusion Criteria

Exclusion Criteria

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00383916

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

No publications provided

Study ID Numbers:	3001B1-119
Study First Received:	October 2, 2006
Last Updated:	March 7, 2007
ClinicalTrials.gov Identifier:	NCT00383916 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Wyeth:

healthy

Additional relevant MeSH terms:

Therapeutic Uses
Pantoprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010