Clinical trial NCT01179659: Bioequivalence Study of Pantoprazole 40 mg DR Tablets and Protonix 40 mg Tablets Under Fed Conditions
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Single dose crossover BE study
Lead sponsor: Kremers Urban Development Company
Sponsor class: INDUSTRY
First posted: 2010-08-11
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Cmax (maximum observed concentration of drug substance in plasma)
timeFrame: 26 hours
measure: AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration)
timeFrame: 26 hours
measure: AUC0-inf (area under the concentration-time curve from time zero to infinity)
timeFrame: 26 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Saint-Laurent, Montreal
country: Canada
facility: MDS Pharma Services
state: Quebec
Study officials:
affiliation: MDS Pharma Services
name: Gaetano morelli, MD
role: PRINCIPAL_INVESTIGATOR
References: