Study Comparing 2 Different Formulations of Pantoprazole in Healthy Adults.

• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00383916
• Collaborator: (none)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy Subjects	Drug: pantoprazole	Phase 1

Detailed Description

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

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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.
• Study Start Date: Oct 1, 2006
• Study Completion Date: Oct 1, 2006

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria

• Men or women aged 18 to 50 years.

• Healthy as determined by the investigator.

Exclusion Criteria

• History or active presence of clinically important medical disease.

• History of drug or alcohol abuse.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Wyeth is now a wholly owned subsidiary of Pfizer

Investigators

• Study Director: Medical Monitor, Wyeth is now a wholly owned subsidiary of Pfizer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00383916
• Other Study ID Numbers: 3001B1-119
• First Posted: Oct 4, 2006
• Last Update Posted: Mar 8, 2007
• Last Verified: Mar 1, 2007

• Keywords provided by , ,: healthy
• Additional relevant MeSH terms: Pantoprazole

Study Results

No Results Posted as of Mar 8, 2007