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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01179659
• Date of registration: 10/08/2010
• Prospective Registration: No
• Primary sponsor: Kremers Urban Development Company
• Public title: Bioequivalence Study of Pantoprazole 40 mg DR Tablets and Protonix 40 mg Tablets Under Fed Conditions
• Scientific 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
• Date of first enrolment: September 2005
• Target sample size: 150
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01179659
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

Canada

Contacts

• Name: Gaetano morelli, MD
• Affiliation: MDS Pharma Services

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 55 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Healthy

Intervention(s)

Drug: Pantoprazole 40 mg DR Tablet vs. Protonix 40 mg DR Tablet

Primary Outcome(s)

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]

Secondary ID(s)

SP872

Source(s) of Monetary Support

Please refer to primary and secondary sponsors