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CompletedNCT00835393Updated Feb 3, 2009

Pantoprazole Sodium 40 mg DR Tablets Under Non-Fasting Conditions

A Phase 1 interventional study of Pantoprazole Sodium 40 mg delayed-release tablets and PROTONIX® 40 mg delayed-release tablets. in Healthy, sponsored by Teva Pharmaceuticals USA. Completed at 2 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-02-03.

Sponsored by Teva Pharmaceuticals USA (part of Teva Pharmaceutical Industries, Ltd.) · Phase 1 and Interventional

Phase
Phase 1
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The Objective of this study is to compare the relative bioavailability of pantoprazole sodium 40 mg delayed-released tablets (manufactured by TEVA Pharmaceutical Industries,Ltd. and distributed by TEVA Pharmaceuticals USA)with that of PROTONIX® 40mg delayed-released tablets (Wyeth- Ayerst) in Healthy, adult, non-smoking subjects under non- fasting conditions.

Read the detailed description

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

02

Conditions studied

  • Healthy

Keywords

  • Bioequivalence
  • Healthy Subjects
03

In context

Lead sponsor

Teva Pharmaceuticals USA is the lead sponsor of 176 studies on the registry; none are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • All subjects selected for this study will be non-smokers at least 18 years of age. Subjects will have a BMI (Body Mass Index) of 30 or less.

Exclusion criteria

Exclusion Criteria:

  • Subjects with a significant recent history of chronic alcohol consumption (past 2 years), drug addiction, or serious gastrointestinal, renal, hepatic or cardiovascular, disease, tuberculosis, epilepsy, asthma (past 5 years), diabetes, psychosis or glaucoma will not be eligible for this study.
  • Subjects whose clinical laboratory test values are greater than 20% outside the normal range may be retested. If the clinical values are outside the range on retesting, the subject will not be eligible to participate in the study unless the clinical investigator deems the result not to be significant.
  • Subjects who have a history of allergic responses to the class of drug being tested will be excluded from the study.
  • All subjects will have urine samples assayed for the presence of drugs of abuse as part of the clinical laboratory screening procedures and at each dosing period check-in. Subjects found to have urine concentrations of any of the tested drugs will not be allowed to participate.
  • Subjects should not have donated blood and/ot plasma for at least thirty (30) days prior to the first dosing of the study.
  • Subjects who have taken any investigational drug within thirty (30) days prior to the first dosing of the study will not be allowed to participate.
  • Female subjects who are pregnant, breast-feeding, or who are likely to become pregnant during the study will not be allowed to participate. Female subjects of child bearing potential must either abstain from sexual intercourse or use a reliable barrier method (e.g. condom, IUD) of contraception during the course of the study (first dosing until last blood collection) or they will not be allowed to participate. Subjects who have used implanted or injected hormonal contraceptives anytime during the 180 days prior to study dosing or oral hormonal contraceptives with in 14 days of dosing will not be allowed to participate.
  • All female subjects will be screened for pregnancy at check-in each study period. Subjects with positive or inconclusive results will be with drawn from the study.
  • Subjects who do not tolerate venipuncture will not be allowed to participate.
  • Subjects who use tobacco in any form will not be eligible to participate in the study. Three months abstinence is required.
05

Study design

Phase
Phase 1
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    1

    Drug: Pantoprazole Sodium 40 mg delayed-release tablets

  • Active comparator
    2

    Drug: PROTONIX® 40 mg delayed-release tablets.

06

What researchers measure

Primary outcomes

  1. Bioequivalence based on Cmax and AUC

    Time frame: 1 month

07

Study locations

2 sites
  • Gateway Medical Research, Inc.
    Saint Charles, Missouri 63301, United States
  • Bioassay Laboratory, Inc.
    Houston, Texas 77099, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 3, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00835393
First posted
Feb 3, 2009
Start date
Dec 2003
Primary completion
Dec 2003
Completion
Dec 2003
Last update
Feb 3, 2009

Study contacts

Steven Herrmann, M.D.; Ph.D
principal investigator · Cetero Research, San Antonio

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2009. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Pantoprazole

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