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

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

Overview[ - collapse ][ - ]

Purpose	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.
Condition	Healthy
Intervention	Drug: Pantoprazole 40 mg DR Tablet vs. Protonix 40 mg DR Tablet
Phase	Phase 1
Sponsor	Kremers Urban Development Company
Responsible Party	Kremers Urban Development Company
ClinicalTrials.gov Identifier	NCT01179646
First Received	August 10, 2010
Last Updated	August 10, 2010
Last verified	August 2010

Tracking Information[ + expand ][ + ]

First Received Date	August 10, 2010
Last Updated Date	August 10, 2010
Start Date	June 2004
Estimated Primary Completion Date	August 2004
Current Primary Outcome Measures	Cmax (maximum observed concentration of drug substance in plasma) [Time Frame: 16 hours] [Designated as safety issue: No] AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration) [Time Frame: 16 hours] [Designated as safety issue: No] AUC0-inf area under the concentration-time curve from time zero to infinity) [Time Frame: 16 hoyurs] [Designated as safety issue: No]
Current Secondary Outcome Measures	Not Provided

Descriptive Information[ + expand ][ + ]

Brief Title	Bioequivalence Study of Pantoprazole 40 mg DR Tablets and Protonix 40 mg Tablets
Official Title	A Pharmacokinetic Study to Determine the Bioequivalence of a Test 40 mg Pantoprazole Delayed-Release Tablet, Compared to a Marketed 40 mg Pantoprazole Delayed-Release Tablet (Protonix, Wyeth Pharmaceuticals) When Administered to Healthy Adult Subjects in the Fasted State
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.
Detailed Description	The 90% CI for pantoprazole ln(Cmax), ln[AUC(0-t)], and ln[AUC(0-inf)] for the comparison of the test product (pantoprazole) versus the reference product (Protonix) should be within the 80 to 125% range required for the conclusion of bioequivalence.
Study Type	Interventional
Study Phase	Phase 1
Study Design	Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition	Healthy
Intervention	Drug: Pantoprazole 40 mg DR Tablet vs. Protonix 40 mg DR Tablet Single dose crossover BE study Other Names: Protonix 40 mg DR Tablet (Wyeth Pharmaceuticals)
Study Arm (s)	Active Comparator: Protonix Protonix 40 mg DR Tablet Experimental: Pantoprazole Pantoprazole 40 mg DR Tablet

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	48
Estimated Completion Date	August 2004
Estimated Primary Completion Date	June 2004
Eligibility Criteria	Inclusion Criteria: - 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. Exclusion Criteria: - 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. - Unwilling to eat the food as provided in the study menu. - Hemoglobin <12.0 g/dL. - History of alcohol or drug abuse within 2 years prior to dosing.
Gender	Both
Ages	19 Years
Accepts Healthy Volunteers	Accepts Healthy Volunteers
Contacts	Not Provided
Location Countries	United States

Administrative Information[ + expand ][ + ]

NCT Number	NCT01179646
Other Study ID Numbers	SP796
Has Data Monitoring Committee	No
Information Provided By	Kremers Urban Development Company
Study Sponsor	Kremers Urban Development Company
Collaborators	Not Provided
Investigators	Principal Investigator: Alan Marion, MD, PhD MDS Pharma Services
Verification Date	August 2010

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