Pantoprazole Sodium 40 mg DR Tablets Under Fasting Conditions

NCT00835588 | Completed Phase 1 Results

• 1 other identifier: B036581
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Healthy

Keywords

Bioequivalence; Healthy Subjects

Outcome Measures

Primary Outcomes (3)

• Cmax - Maximum Observed Concentration - Pantoprazole in Plasma

  Bioequivalence based on Cmax

  Blood samples collected over 16 hour period

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

  Bioequivalence based on AUC0-inf

  Blood samples collected over 16 hour period

• 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

  Blood samples collected over 16 hour period

Study Arms (2)

Pantoprazole

EXPERIMENTAL

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

Protonix®

ACTIVE COMPARATOR

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.

Interventions

Pantoprazole Sodium 40 mg delayed-release tablets DRUG

1 x 40 mg

Pantoprazole

PROTONIX® 40 mg delayed-release tablets. DRUG

1 x 40 mg

Protonix®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Teva Pharmaceuticals USA: lead

Study Sites (2)

Gateway Medical Research, Inc.

Saint Charles, Missouri, 63301, United States

Location

Bioassay Laboratory, Inc.

Houston, Texas, 77099, United States

Location

MeSH Terms

Interventions

Pantoprazole

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Manager, Biopharmaceutics
• Organization: Teva Pharmaceuticals USA

clinicaltrialqueries@tevausa.com

1-866-384-5525

Study Officials

• Steven Herrmann, M.D.; Ph.D

  Cetero Research, San Antonio

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 2, 2009
• First Posted: February 3, 2009
• Study Start: December 1, 2003
• Primary Completion: December 1, 2003
• Study Completion: December 1, 2003
• Last Updated: August 20, 2024
• Results First Posted: August 18, 2009

Record last verified: 2024-08

Locations

US (2)