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Bioequivalence Study of Pantoprazole 40 mg DR Tablets and Protonix 40 mg Tablets Under Fed Conditions

NCT01179659 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2010-08-11

No results posted yet for this study

Summary

The objective of this study was to assess the single-dose bioequivalence of KUDCO's and Wyeth Pharmaceuticals' (Protonix) 40 mg pantoprazole sodium delayed-lease tablets, under fed conditions.

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

  • Gaetano morelli, MD · MDS Pharma Services

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-09-30
Primary Completion
2005-11-30
Completion
2006-03-31

Countries

  • Canada

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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 NCT01179659 on ClinicalTrials.gov