NCT00383916

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Oct 2006

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

October 2, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 4, 2006

Completed
Last Updated

March 8, 2007

Status Verified

March 1, 2007

First QC Date

October 2, 2006

Last Update Submit

March 7, 2007

Conditions

Healthy Subjects

Keywords

healthy

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Interventions

pantoprazoleDRUG

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Men or women aged 18 to 50 years.
  • Healthy as determined by the investigator.

You may not qualify if:

  • History or active presence of clinically important medical disease.
  • History of drug or alcohol abuse.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Pantoprazole

Intervention Hierarchy (Ancestors)

2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Medical Monitor

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 2, 2006

First Posted

October 4, 2006

Study Start

October 1, 2006

Study Completion

October 1, 2006

Last Updated

March 8, 2007

Record last verified: 2007-03