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

NCT01179659 | Completed Phase 1

• 1 other identifier: SP872
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Single dose crossover BE study

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Protonix

ACTIVE COMPARATOR

Protonix 40 mg DR Tablet (Wyeth Pharmaceuticals)

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

Pantoprazole 40 mg DR Tablet

EXPERIMENTAL

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

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

Interventions

Pantoprazole 40 mg DR Tablet vs. Protonix 40 mg DR Tablet DRUG

Single dose crossover BE study

Pantoprazole 40 mg DR Tablet; Protonix

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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:
• Surgically sterile (bilateral tubal ligation, hysterectomy, bilateral oophorectomy) 6 months minimum.
• Intrauterine device (IUD) in place for at least 3 months.
• Barrier method (condom, diaphragm) with spermicide for at least 14 days prior to the first dose and throughout the study.
• Surgical sterilization of the partner (vasectomy for 6 months minimum).
• 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.

You may not qualify if:

• History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease.
• In addition, history or presence of:
• Alcoholism or drug abuse within the past 2 years;
• 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:
• mL of blood in 14 days;
• mL of blood in 180 days;
• mL of blood in one years.
• Subjects who participated in another clinical trial with 28 days prior to the first dose.

Sponsors & Collaborators

• Kremers Urban Development Company: lead

Study Sites (1)

MDS Pharma Services

Saint-Laurent, Montreal, Quebec, H4R 2N6, Canada

Location

MeSH Terms

Interventions

Pantoprazole

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Gaetano morelli, MD

  MDS Pharma Services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 10, 2010
• First Posted: August 11, 2010
• Study Start: September 1, 2005
• Primary Completion: November 1, 2005
• Study Completion: March 1, 2006
• Last Updated: August 11, 2010

Record last verified: 2010-08

Locations

CA (1)