Bioequivalence Study of Pantoprazole Sodium 40 mg Delayed Release Tablets Fed Study

NCT01654718 | Completed

• 1 other identifier: 251_PANTO_08
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study was to compare the single-dose oral bioequivalence of Pantoprazole sodium 40 mg delayed release tablets (containing 45.1 mg of Pantoprazole sodium sesquihydrate is equivalent to 40 mg of Pantoprazole) of OHM Laboratories Inc. USA (a subsidiary of Ranbaxy Pharmaceuticals Inc. USA) with PROTONIX® 40 mg delayed release tablets (containing 45.1 mg of Pantoprazole sodium sesquihydrate is equivalent to 40 mg of Pantoprazole) of Wyeth Laboratories, USA in healthy, adult, human, male subjects under fed conditions.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Composite of Pharmacokinetics

  Cmax, Area Under Curve and Tmax

  Predose and at 1.00, 2.00, 3.00, 3.50, 4.00, 4.50, 5.00, 5.50, 6.00, 6.50, 7.00, 7.50, 8.00, 8.50, 9.00, 9.50, 10.00, 10.50, 11.00, 12.00, 13.00, 14.00, 15.00, 16.00, 17.00, 18.00, 19.00, 20.00, 22.00, 24.00, 36.00 and 48.00 hours

Study Arms (2)

Pantoprazole Sodium Delayed release tablets

EXPERIMENTAL

Pantoprazole Sodium Delayed release tablets USP 40 mg of OHM Laboratories Inc.,USA

Drug: Pantoprazole

Protonix® Delayed Release 40 mg tablets

ACTIVE COMPARATOR

Protonix® Delayed Release 40 mg tablets of Wyeth Pharmaceuticals Inc.USA

Drug: Pantoprazole

Interventions

Pantoprazole DRUG

Pantoprazole 40mg Delayed release tablets (Test Product)

Pantoprazole Sodium Delayed release tablets

Eligibility Criteria

• Age: 20 Years - 37 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Volunteers who met the following criteria were included in the study
• Were in the age range of 18-45 years.
• Were neither overweight nor underweight for his height as per the Life Insurance Corporation of India height/weight chart for non-medical cases.
• Had voluntarily given written informed consent to participate in this study.
• Were of normal health as determined by medical history and physical examination of the subjects performed within 21 days prior to the commencement of the study.
• Had non-vegetarian dietary habit.
• There were no deviations in this regard

You may not qualify if:

• History of allergy or hypersensitivity to Pantoprazole and/or any other drugs.
• Any evidence of organ dysfunction or any clinically significant deviation from the normal, in physical or clinical determinations.
• Presence of disease markers of HIV 1 or 2, Hepatitis B or C viruses or syphilis infection.
• Presence of values which were out of acceptable limits for haemoglobin, total white blood cells count, differential WBC count or platelet count.
• Positive for urinary screen testing of drugs of abuse (opiates or cannabinoids).
• Presence of values which were out of acceptable limits for serum creatinine, blood urea nitrogen, serum aspartate aminotransferase (AST), serum alanine aminotransferase (ALT), serum alkaline phosphatase, serum bilirubin, plasma glucose or serum cholesterol.
• Clinically abnormal chemical and microscopic examination of urine defined as presence of RBC, WBC (\>4/HPF), epithelial cells (\>4/HPF), glucose (positive) or protein (positive).
• Clinically abnormal ECG or Chest X-ray.
• History of serious gastrointestinal, hepatic, renal, cardiovascular, pulmonary, neurological or haematological disease, diabetes or glaucoma.
• History of any psychiatric illness which might impair the ability to provide written informed consent.
• Regular smokers who smoked more than 10 cigarettes daily or had difficulty abstaining from smoking for the duration of each study period.
• History of drug dependence or excessive alcohol intake on a habitual basis of more than 2 units of alcoholic beverages per day (1 unit equivalent to half pint of beer or 1 glass of wine or 1 measure of spirit) or had difficulty in abstaining for the duration of each study period.
• Use of any enzyme modifying drugs within 30 days prior to Day 1 of this study.
• Participation in any clinical trial within 12 weeks preceding Day 1 of this study.
• Subjects who, through completion of this study, would have donated and /or lost more than 350 ml of blood in the past 3 months other than study participation.

Sponsors & Collaborators

• Ranbaxy Laboratories Limited: lead

Study Sites (1)

Clinical Pharmacology Unit, Ranbaxy Laboratories Limited

Noida, Uttar Pradesh, India

Location

Related Links

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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 Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2012
• First Posted: August 1, 2012
• Study Start: October 1, 2008
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2009
• Last Updated: August 1, 2012

Record last verified: 2012-06

Locations

IN (1)