ClinicalTrials.gg
Sign In
CompletedNCT00835588Updated Aug 20, 2024Results posted

Pantoprazole Sodium 40 mg DR Tablets Under 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 2024-08-20.

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

Phase
Phase 1
Study type
Interventional
Enrollment
100
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-release tablets ( manufactured by TEVA Pharmaceuticals Industries, Ltd. and distributed by TEVA Pharmaceuticals USA) with that of PROTONIX® 40 mg delayed-released tablets (Wyeth-Ayerst) in Healthy, adult, non-smoking subjects under 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.

Browse Teva Pharmaceuticals USA studies →All Teva Pharmaceutical Industries, Ltd. studies →

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/or plasma for at least 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 withdrawn from the study.
  • Subjects who do no 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
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    Pantoprazole

    Pantoprazole Sodium 40 mg DR Tablet (test) dosed in first period followed by Protonix® 40 mg DR Tablet (reference) dosed in second period

    Drug: Pantoprazole Sodium 40 mg delayed-release tablets

  • Active comparator
    Protonix®

    Protonix 40 mg DR Tablet (reference) dosed in first period followed by Pantoprazole Sodium 40 mg DR Tablet (test) dosed in second period

    Drug: PROTONIX® 40 mg delayed-release tablets.

06

What researchers measure

Primary outcomes

  1. Cmax - Maximum Observed Concentration - Pantoprazole in Plasma

    Bioequivalence based on Cmax

    Time frame: Blood samples collected over 16 hour period

  2. AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)

    Bioequivalence based on AUC0-inf

    Time frame: Blood samples collected over 16 hour period

  3. AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)

    Bioequivalence based on AUC0-t

    Time frame: Blood samples collected over 16 hour period

07

Results

Posted Aug 18, 2009

Participant flow

First Intervention
Participant flow — First Intervention
MilestonePantoprazole (Test) FirstProtonix® (Reference) First
Started5050
Completed5050
Not completed00
Washout: 5 Days
Participant flow — Washout: 5 Days
MilestonePantoprazole (Test) FirstProtonix® (Reference) First
Started5050
Completed5050
Not completed00
Second Intervention
Participant flow — Second Intervention
MilestonePantoprazole (Test) FirstProtonix® (Reference) First
Started5050
Completed5050
Not completed00

Outcome measures

PrimaryCmax - Maximum Observed Concentration - Pantoprazole in Plasma

Bioequivalence based on Cmax

Time frame:
Blood samples collected over 16 hour period
Reported as:
Mean · ng/mL
Cmax - Maximum Observed Concentration - Pantoprazole in Plasma
ng/mLPantoprazoleProtonix®
Cmax - Maximum Observed Concentration - Pantoprazole in Plasma2494.120 ± 965.0222747.380 ± 879.942
Statistical analysis
  • Pantoprazole vs Protonix® · Geometric test/ref ratio x 100: 88.8 · 90% CI 82.7 to 95.4Bioequivalence is established when 90% Confidence Interval falls within 80-125.
PrimaryAUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)

Bioequivalence based on AUC0-inf

Time frame:
Blood samples collected over 16 hour period
Reported as:
Mean · ng*h/mL
AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)
ng*h/mLPantoprazoleProtonix®
AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)6280.022 ± 6311.0336332.279 ± 5923.458
Statistical analysis
  • Pantoprazole vs Protonix® · Geometric test/ref ratio x 100: 97.3 · 90% CI 93.4 to 101Bioequivalence is established when 90% Confidence Interval falls within 80-125.
PrimaryAUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)

Bioequivalence based on AUC0-t

Time frame:
Blood samples collected over 16 hour period
Reported as:
Mean · ng*h/mL
AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)
ng*h/mLPantoprazoleProtonix®
AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)5822.470 ± 4825.9286016.176 ± 4502.333
Statistical analysis
  • Pantoprazole vs Protonix® · Geometric test/ref ratio x 100: 95.6 · 90% CI 91.6 to 99.8Bioequivalence is established when 90% Confidence Interval falls within 80-125.

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Pantoprazole (Test) FirstProtonix® (Reference) FirstTotal
<=18 years000
Between 18 and 65 years5050100
>=65 years000
Sex: Female, Male
Sex: Female, Male(Participants)Pantoprazole (Test) FirstProtonix® (Reference) FirstTotal
Female191433
Male313667
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Pantoprazole (Test) FirstProtonix® (Reference) FirstTotal
Caucasian414283
Black5510
American Indian112
Asian101
Hispanic213
Other011
Region of Enrollment
Region of Enrollment(participants)Pantoprazole (Test) FirstProtonix® (Reference) FirstTotal
United States5050100
08

Study locations

2 sites
  • Gateway Medical Research, Inc.
    Saint Charles, Missouri 63301, United States
  • Bioassay Laboratory, Inc.
    Houston, Texas 77099, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 20, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00835588
Lead sponsor
Teva Pharmaceuticals USA
First posted
Feb 3, 2009
Start date
Dec 2003
Primary completion
Dec 2003
Completion
Dec 2003
Results posted
Aug 18, 2009
Last update
Aug 20, 2024

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 Aug 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Pantoprazole

Other studies from this sponsor

Teva Pharmaceuticals USA →

Start the discussion