Bioequivalence Study of Pantoprazole 40 mg DR Tablets and Protonix 40 mg Tablets

A Pharmacokinetic Study to Determine the Bioequivalence of a Test 40 mg Pantoprazole Delayed-Release Tablet, Compared to a Marketed 40 mg Pantoprazole Delayed-Release Tablet (Protonix, Wyeth Pharmaceuticals) When Administered to Healthy Adult Subjects in the Fasted State

The objective of this study was to determine the single-dose bioequivalence of the test product, a potential generic 40 mg pantoprazole delayed-release tablet formulation, compared with the reference product, a pantoprazole 40 mg delayed-release tablet formulation (Protonix, Wyeth Pharmaceuticals), following a single dose in the fasted state.

Study Overview

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

Detailed Description

The 90% CI for pantoprazole ln(Cmax), ln[AUC(0-t)], and ln[AUC(0-inf)] for the comparison of the test product (pantoprazole) versus the reference product (Protonix) should be within the 80 to 125% range required for the conclusion of bioequivalence.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Lincoln, Nebraska, United States, 68502
      • MDS Pharma Services

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Non tobacco/nicotine-using (6 months minimum) healthy males and females between 19 and 50 years of age.
• Body weight from 15% below or 15% above, inclusive, the ideal weight for height and estimated frame, as adapted from the 1983 Metropolitan Life Table.
• Female subjects were surgically sterile, at least two years postmenopausal, or if sexually active, had a partner who had been vasectomized for at least 6 months, or agreed to utilize one of the following forms of contraception: barrier (condom with spermicide or diaphragm with spermicide), IUD, or hormonal (oral, implant, transdermal patch, or injection) for the following specified times.

Subjects using hormonal contraceptives were on a stable dose for 3 months prior to dosing, or they agreed to also use a barrier method of birth control from screening through completion of the study. Subjects having an intrauterine device (IUD) must have had the IUD in place for at least 2 months prior to dosing, or they agreed to also use a barrier method of birth control from screening through completion of the study. For other forms of birth control, the subject had used the method at least 2 weeks prior to screening and agreed to use the method through completion of the study.

• Voluntary consent to participate in this study as demonstrated by signing the informed consent form.

Exclusion Criteria:

• Persons of Asian origin.
• Females who were pregnant or lactating.
• History of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease, or any other condition that, in the opinion of the Investigator, could jeopardize the safety of the subject or impact the validity of the study results.
• History of hypersensitivity, allergic or adverse response to pantoprazole or related drugs.
• Positive results from HIV antibody screen, hepatitis B surface antigen screen, and/or hepatitis C antibody screen.
• Participation in a previous clinical trial within 30 days prior to study initiation.
• Donation of one pint or more of whole blood within 56 days prior to study initiation.
• Donation of 2 units of red blood cells within 112 days prior to study initiation.
• Donation of plasma with 7 days prior to study initiation.
• Difficulty in swallowing medication or any gastrointestinal disease that could affect the drug absorption.
• Abnormal diet or substantial changes in eating habits within 30 days prior to study initiation. Examples included, but were not limited to, vegetarian, fasting, or liquid supplement, etc.
• Treatment with any known enzyme-altering agents (barbiturates, phenothiazines, or cimetidine, etc.) within 30 days prior to study initiation.
• Use of any prescription medication (except hormonal contraceptives for females) within 14 days prior to study initiation.
• Use of any over-the-counter (OTC) medication, including mega-dose vitamins, analgesics, herbal/nutritional supplements, and antacids, within 7 days prior to study initiation.
• Positive urine screen for alcohol or drugs of abuse.
• Unwilling to eat the food as provided in the study menu.
• Hemoglobin <12.0 g/dL.
• History of alcohol or drug abuse within 2 years prior to dosing.

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	Drug: Pantoprazole 40 mg DR Tablet vs. Protonix 40 mg DR Tablet; Single dose crossover BE study; Other Names: Protonix 40 mg DR Tablet (Wyeth Pharmaceuticals)
Experimental: Pantoprazole; Pantoprazole 40 mg DR Tablet	Drug: Pantoprazole 40 mg DR Tablet vs. Protonix 40 mg DR Tablet; Single dose crossover BE study; Other Names: Protonix 40 mg DR Tablet (Wyeth Pharmaceuticals)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cmax (maximum observed concentration of drug substance in plasma)	16 hours
AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration)	16 hours
AUC0-inf area under the concentration-time curve from time zero to infinity)	16 hoyurs

Collaborators and Investigators

• Sponsor: Kremers Urban Development Company
• Investigators: Principal Investigator: Alan Marion, MD, PhD, MDS Pharma Services

Study record dates

Study Major Dates

• Study Start: June 1, 2004
• Primary Completion (Actual): June 1, 2004
• Study Completion (Actual): August 1, 2004

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: Bioequivalency
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Pantoprazole
• Other Study ID Numbers: SP796