A Relative Bioavailability Study of 20 mg Famotidine Tablets Under Fasting Condition

March 1, 2010 updated by: Ranbaxy Laboratories Limited

An Open Label, Balanced, Randomized, Two-treatment, Two-period, Two-sequence, Single-dose, Crossover Bioavailability Study Comparing Famotidine 20 mg Tablets of OHM Laboratories (a Subsidiary of Ranbaxy Pharmaceutical Inc.) With PEPCID AC Tablets (Containing Famotidine 20 mg) of Johnson & Johnson Merck Consumer Pharmaceutical Co. in Healthy, Adult, Human, Male Subjects Under Fasting Condition.

The study was conducted as an open-label, balanced, randomized, two-treatment, two-period, two-sequence, single-dose, crossover, bioavailability study comparing famotidine tablets, USP 20 mg manufactured by OHM Laboratories with Pepcid® AC Acid reducer famotidine tablets 20 mg (containing famotidine 20 mg) distributed by Johnson & Johnson. Merck Consumer Pharmaceutical Co. Fort Washington, PA 19034 USA under fasting conditions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Following an overnight fast of at least 10 hour, a single oral dose of famotidine tablets, USP 20 mg or Pepcid® AC Acid reducer famotidine tablets 20 mg (containing famotidine 20 mg) was administered during each period of the study, along with 240 mL of drinking water at ambient temperature and under supervision of trained study personnel.

During the course of the study, safety parameters assessed were vital signs, clinical examination, medical history and clinical laboratory safety tests (hematology, biochemical parameters, serology and urine analysis) at baseline. Adverse event monitoring was done throughout the study. Laboratory parameters of hematology and biochemistry (except blood glucose and cholesterol) were repeated at the end of the study for all the subjects.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Uttar Pradesh
      • Noida, Uttar Pradesh, India
        • Ranbaxy Clinical Pharmacology Unit, Ranbaxy Laboratories Limited

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Were in the age range of 18-45 years.
  • Were neither overweight nor underweight for their corresponding 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.

There were no deviations in this regard.

Exclusion Criteria:

  • History of hypersensitivity to famotidine and/or related group of drugs, including hypersensitivity to H2 blockers.
  • The subject had evidence of organ dysfunction or any clinically significant deviation from the normal, in physical or clinical determinations.
  • Investigations with blood samples of the subject showed presence of disease markers of HIV 1 or 2, Hepatitis B or C viruses or syphilis infection.
  • Investigations with blood samples of the subject showed the presence of values which are significantly different from normal reference range and/or judged clinically significant 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)
  • Investigations with blood samples of the subject showed the presence of values which are significantly different from normal reference range and/or judged clinically significant for serum creatinine, blood urea, serum aspartate aminotransferase (AST), serum alanine aminotransferase (ALT), serum alkaline phosphatase, serum bilirubin, plasma glucose or serum cholesterol.
  • Investigations with urine samples of the subject showed 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.
  • The subject had history of serious gastrointestinal, hepatic, renal, pulmonary, cardiovascular, neurological or haematological disease, diabetes or glaucoma.
  • The subject had history of any psychiatric illness, which may impair the ability to provide written informed consent.
  • The subject was a regular smoker who smoked more than 10 cigarettes daily or has difficulty abstaining from smoking for the duration of each study period.
  • The subject had 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.
  • The subject had participated 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.

There were no deviations in this regard.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Test
Famotidine Tablets, USP 20 mg of OHM Laboratories Inc (A subsidiary of Ranbaxy Pharmaceuticals Inc., USA)
Drug: Famotidine
Tablets
Active Comparator: Reference
Pepcid® AC Acid reducer famotidine tablets 20 mg of Johnson & Johnson. Merck Consumer Pharmaceutical Co. Fort Washington, PA 19034 USA
Drug: Famotidine
Tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Bioequivalence evaluation of ranbaxy famotidine tablets 20mg with Pepcid® AC Acid reducer famotidine tablets 20 mg under fasting condition

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ranbaxy Laboratories Limited

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Actual)

November 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

February 18, 2010

First Submitted That Met QC Criteria

March 1, 2010

First Posted (Estimate)

March 2, 2010

Study Record Updates

Last Update Posted (Estimate)

March 2, 2010

Last Update Submitted That Met QC Criteria

March 1, 2010

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 261_FAMOT_07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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