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

This study has been completed.
Sponsor:
Information provided by:
Kremers Urban Development Company
ClinicalTrials.gov Identifier:
NCT01179659
First received: August 10, 2010
Last updated: NA
Last verified: August 2010
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: Pantoprazole 40 mg DR Tablet vs. Protonix 40 mg DR Tablet
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pharmacokinetic Study to Assess the Bioequivalence of a Single-Dose of KUDCO and Wyeth Pharmaceuticals (Protonix) 40 mg Pantoprazole Sodium Delayed-Release Tablet When Administered to Healthy Adult Volunteers Under Fed Conditions

Resource links provided by NLM:


Further study details as provided by Kremers Urban Development Company:

Primary Outcome Measures:
  • Cmax (maximum observed concentration of drug substance in plasma) [ Time Frame: 26 hours ]
  • AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration) [ Time Frame: 26 hours ]
  • AUC0-inf (area under the concentration-time curve from time zero to infinity) [ Time Frame: 26 hours ]

Enrollment: 150
Study Start Date: September 2005
Study Completion Date: March 2006
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Protonix
Protonix 40 mg DR Tablet (Wyeth Pharmaceuticals)
Drug: Pantoprazole 40 mg DR Tablet vs. Protonix 40 mg DR Tablet
Single dose crossover BE study
Experimental: Pantoprazole 40 mg DR Tablet
Pantoprazole 40 mg DR Tablet vs. Protonix 40 mg DR Tablet
Drug: Pantoprazole 40 mg DR Tablet vs. Protonix 40 mg DR Tablet
Single dose crossover BE study

Detailed Description:

This was an open-label, randomized, fully replicated crossover, 2-sequence bioequivalence study under fed conditions.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy, adult, non-smoking (for at least 6 months) male or female volunteers, 18 - 55 years of age.
  • Weighed at least 52 kg for males and 45 kg for females and within 15% of their ideal weights (Table of "Desirable Weights of Adults", Metropolitan Life Insurance Company, 1983).
  • Medically healthy subjects with clinically normal laboratory profiles, vital signs, and ECG.
  • Females of childbearing potential were either sexually inactive (abstinent) for 14 days prior to the first dose and throughout the study, or using one of the following acceptable birth control methods:

    1. Surgically sterile (bilateral tubal ligation, hysterectomy, bilateral oophorectomy) 6 months minimum.
    2. Intrauterine device (IUD) in place for at least 3 months.
    3. Barrier method (condom, diaphragm) with spermicide for at least 14 days prior to the first dose and throughout the study.
    4. Surgical sterilization of the partner (vasectomy for 6 months minimum).
    5. Hormonal contraceptives for at least 3 months prior to the first dose of the study.
  • Gave voluntary written informed consent to participate in the study.

Exclusion Criteria:

  • History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease.
  • In addition, history or presence of:

    1. Alcoholism or drug abuse within the past 2 years;
    2. Hypersensitivity or idiosyncratic reaction to pantoprazole, omeprazole, or any other substituted benzimidazole proton-pump. inhibitors.
  • Females who were pregnant or lactating.
  • History of tobacco use or use of products containing nicotine (i.e., smoking cessation aids such as nicotine gum or patches) within the 6 months prior to the first dose.
  • Subjects who tested positive at screening for human immunodeficiency virus (HIV) antibody screen, hepatitis B surface antigen screen (HbsAg), or hepatitis C antibody screen (HCV).
  • Treatment with any known enzyme-altering drugs (barbiturates, phenothiazines, cimetidine, etc.) within 30 days prior to the first dose.
  • Difficulty in swallowing medication or any gastrointestinal disease that would affect the drug absorption.
  • Subjects who had been on a special diet (for whatever reason) during the 28 days prior to the first dose and throughout the study.
  • Subjects who, through completion of the study, would have donated in excess of:

    • 500 mL of blood in 14 days;
    • 1500 mL of blood in 180 days;
    • 2500 mL of blood in one years.
  • Subjects who participated in another clinical trial with 28 days prior to the first dose.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01179659

Locations
Canada, Quebec
MDS Pharma Services
Saint-Laurent, Montreal, Quebec, Canada, H4R 2N6
Sponsors and Collaborators
Kremers Urban Development Company
Investigators
Principal Investigator: Gaetano morelli, MD MDS Pharma Services
  More Information

No publications provided

Responsible Party: Gartano Morelli, MD, MDS Pharma Services
ClinicalTrials.gov Identifier: NCT01179659     History of Changes
Other Study ID Numbers: SP872
Study First Received: August 10, 2010
Last Updated: August 10, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Kremers Urban Development Company:
Single dose crossover BE study

Additional relevant MeSH terms:
Pantoprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 14, 2014