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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Pantoprazole 40 mg DR Tablet vs. Protonix 40 mg DR Tablet

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Saint-Laurent, Montreal, Quebec, Canada, H4R 2N6
      • MDS Pharma Services

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 51 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Kremers Urban Development Company

Study record dates

Study Major Dates

• Study Start: September 1, 2005
• Primary Completion (Actual): November 1, 2005
• Study Completion (Actual): March 1, 2006

Study Registration Dates

• First Submitted: August 10, 2010
• First Submitted That Met QC Criteria: August 10, 2010
• First Posted (Estimate): August 11, 2010

Study Record Updates

• Last Update Posted (Estimate): August 11, 2010
• Last Update Submitted That Met QC Criteria: August 10, 2010
• Last Verified: August 1, 2010

More Information

Terms related to this study

• Keywords: Single dose crossover BE study
• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Pantoprazole
• Other Study ID Numbers: SP872