Study Comparing 2 Different Formulations of Pantoprazole in Healthy Adults.

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

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Key information

Conditions

Healthy Subjects

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pantoprazole

Drug

Primary outcomes

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

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Industry

Registry information

Official study 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.

Important dates

Study start: 2006
Study completion: 2006
First posted: Oct 4, 2006
Registry last updated: Mar 8, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed