MedTrace Logo

Bioequivalence Study of Pantoprazole 40 mg DR Tablets and Protonix 40 mg Tablets

NCT01179646 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2010-08-11

No results posted yet for this study

Summary

The objective of this study was to determine the single-dose bioequivalence of the test product, a potential generic 40 mg pantoprazole delayed-release tablet formulation, compared with the reference product, a pantoprazole 40 mg delayed-release tablet formulation (Protonix, Wyeth Pharmaceuticals), following a single dose in the fasted state.

Conditions

  • Healthy

Interventions

DRUG

Pantoprazole 40 mg DR Tablet vs. Protonix 40 mg DR Tablet

Single dose crossover BE study

Sponsors & Collaborators

  • Kremers Urban Development Company

    lead INDUSTRY

Principal Investigators

  • Alan Marion, MD, PhD · MDS Pharma Services

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-06-30
Primary Completion
2004-06-30
Completion
2004-08-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01179646 on ClinicalTrials.gov