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

NCT01179646 | Completed Phase 1

• 1 other identifier: SP796
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

Bioequivalency

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Protonix

ACTIVE COMPARATOR

Protonix 40 mg DR Tablet

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

Pantoprazole

EXPERIMENTAL

Pantoprazole 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

Also known as: Protonix 40 mg DR Tablet (Wyeth Pharmaceuticals)

Pantoprazole; Protonix

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kremers Urban Development Company: lead

Study Sites (1)

MDS Pharma Services

Lincoln, Nebraska, 68502, United States

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

• Alan Marion, MD, PhD

  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: June 1, 2004
• Primary Completion: June 1, 2004
• Study Completion: August 1, 2004
• Last Updated: August 11, 2010

Record last verified: 2010-08

Locations

US (1)