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Bioequivalence Study of Pantoprazole Sodium 40 mg Delayed Release Tablets Fasting Study

NCT01654705 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2012-08-01

No results posted yet for this study

Summary

This study was to compare the single-dose oral bioequivalence of Pantoprazole sodium 40 mg delayed release tablets (containing 45.1 mg of Pantoprazole sodium sesquihydrate equivalent to 40 mg of Pantoprazole) of OHM Laboratories Inc. USA (a subsidiary of Ranbaxy Pharmaceuticals Inc. USA) with PROTONIX® 40 mg delayed release tablets (containing 45.1 mg of Pantoprazole sodium sesquihydrate equivalent to 40 mg of Pantoprazole) of Wyeth Pharmaceuticals Inc., USA in healthy, adult, human, male subjects under fasting conditions.condition.

Conditions

  • Healthy

Interventions

DRUG

Pantoprazole

Pantoprazole 40mg Delayed release tablets (Test Product)

DRUG

Pantoprazole

Protonix® Delayed Release 40 mg tablets (Reference product)

Sponsors & Collaborators

  • Ranbaxy Laboratories Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
19 Years
Max Age
43 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2009-09-30
Completion
2009-12-31

Countries

  • India

Study Locations

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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 NCT01654705 on ClinicalTrials.gov