Study Comparing 2 Different Formulations of Pantoprazole in Healthy Adults.

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.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00383916

Enrollment

Unknown

Registered

2006-10-04

Start date

2006-10-31

Completion date

2006-10-31

Last updated

2007-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Subjects

Keywords

healthy

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

Interventions

DRUGpantoprazole

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

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.

Design outcomes

Primary

Measure	Time frame
To determine the bioequivalence of the Altana formulation of pantoprazole to the Wyeth formulation of pantoprazole delayed-release granules.	—

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026