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

Overview[ - collapse ][ - ]

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.
ConditionHealthy
InterventionDrug: Pantoprazole 40 mg DR Tablet vs. Protonix 40 mg DR Tablet
PhasePhase 1
SponsorKremers Urban Development Company
Responsible PartyKremers Urban Development Company
ClinicalTrials.gov IdentifierNCT01179659
First ReceivedAugust 10, 2010
Last UpdatedAugust 10, 2010
Last verifiedAugust 2010

Tracking Information[ + expand ][ + ]

First Received DateAugust 10, 2010
Last Updated DateAugust 10, 2010
Start DateSeptember 2005
Estimated Primary Completion DateMarch 2006
Current 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]
Current Secondary Outcome MeasuresNot Provided

Descriptive Information[ + expand ][ + ]

Brief TitleBioequivalence Study of Pantoprazole 40 mg DR Tablets and Protonix 40 mg Tablets Under Fed Conditions
Official TitleA 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
Brief Summary
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.
Detailed Description
This was an open-label, randomized, fully replicated crossover, 2-sequence bioequivalence
study under fed conditions.
Study TypeInterventional
Study PhasePhase 1
Study DesignAllocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
ConditionHealthy
InterventionDrug: Pantoprazole 40 mg DR Tablet vs. Protonix 40 mg DR Tablet
Single dose crossover BE study
Study Arm (s)
  • Active Comparator: Protonix
    Protonix 40 mg DR Tablet (Wyeth Pharmaceuticals)
  • Experimental: Pantoprazole 40 mg DR Tablet
    Pantoprazole 40 mg DR Tablet vs. Protonix 40 mg DR Tablet

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment150
Estimated Completion DateMarch 2006
Estimated Primary Completion DateNovember 2005
Eligibility 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.
GenderBoth
Ages18 Years
Accepts Healthy VolunteersAccepts Healthy Volunteers
ContactsNot Provided
Location CountriesCanada

Administrative Information[ + expand ][ + ]

NCT Number NCT01179659
Other Study ID NumbersSP872
Has Data Monitoring CommitteeNo
Information Provided ByKremers Urban Development Company
Study SponsorKremers Urban Development Company
CollaboratorsNot Provided
Investigators Principal Investigator: Gaetano morelli, MD MDS Pharma Services
Verification DateAugust 2010

Locations[ + expand ][ + ]

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