Bioequivalency Study of Ranitidine Tablets 300 mg of Dr. Reddy's Under Fasting Conditions

This study has been completed.
Sponsor:
Information provided by:
Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier:
NCT01131702
First received: May 26, 2010
Last updated: June 8, 2010
Last verified: June 2010
  Purpose

The purpose of this study is to compare the rate and extent of absorption of ranitidine 300 mg tablets versus Zantac 300 mg tablets administered as 1 x 300 mg tablet under fasting conditions.


Condition Intervention Phase
Healthy
Drug: Ranitidine
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized,2-way Crossover, Bioequivalence Study of Ranitidine 300 mg Tablets Zantac 300 mg Tablets Administered as 1 x 300 mg Tablet in Healthy Subjects Under Fasting Conditions

Resource links provided by NLM:


Further study details as provided by Dr. Reddy's Laboratories Limited:

Primary Outcome Measures:
  • Bioequivalence based on Cmax and AUC parameters [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: January 2003
Study Completion Date: March 2003
Primary Completion Date: February 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ranitidine Tablets, 300 mg
Ranitidine Tablets, 300 mg of Dr. Reddy's Laboratories Limited
Drug: Ranitidine
Ranitidine Tablets, 300 mg
Other Name: Zantac 300 mg tablets of Glaxosmithkline
Active Comparator: Zantac Tablets, 300 mg Drug: Ranitidine
Ranitidine Tablets, 300 mg
Other Name: Zantac 300 mg tablets of Glaxosmithkline

Detailed Description:

This study compared the rate and extent of absorption of ranitidine 300 rng tablets versus Zantac. The study products were administered as a single oral dose of 1 x 300 mg tablet using a randomized, two-way crossover fasting study in non-smoker healthy volunteers with a washout period of 7 days.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects enrolled in this study will be members of the community at large. The recruitment advertisements may be done using different media (e.g. radio, newspaper, Anapharm Inc. Web site. Anapharm Inc. volunteers' data base). Subjects must meet all of the following criteria in order to be included in the study:

    • Subjects will be females and/or males, non-smokers, 18 years of age and older.

Exclusion Criteria:

  • Subjects to whom any of the following applies will be excluded from the study:

    • Clinically significant illnesses within 4 weeks of the administration of study medication.
    • Clinically significant surgery within 4 weeks prior to the administration of the study medication.
    • Any clinically significant abnormality found during medical screening.
    • Any reason which, in the opinion of the medical sub investigator would prevent the subject from participating in the study.
    • Abnormal laboratory tests judged clinically significant.
    • Positive urine drug screen at screening.
    • Positive testing for hepatitis B, hepatitis C or HIV at screening.
    • ECG abnormalities (clinically significant) or vital sign abnormalities (systolic blood pressure lower than 90 or over 140 mmHg, or diastolic blood pressure lower than 50 or over 90 mmHg; or heart rate less than 50 or over 100 bpm) at screening.
    • Subjects with BMI ≥ 30.0.
    • History of significant alcohol abuse within six months of the screening visit or any indication of the regular use of more than fourteen units of alcohol per week (1 Unit = 150 mL of wine or 360 mL of beer or 45 mL of alcohol 40%).
    • History of-drug abuse or use of illegal drugs: use of soft drugs (such as marijuana) within 3 months of the screening visit or hard drugs (such as cocaine, phencyclidine (PCP) and crack) within 1 year of the screening visit.
    • History of allergic reactions to ranitidine or other Hr receptor antagonists (e.g.cimetidine, famotidine, nizatidine).
    • History of allergic reactions to heparin.
    • Use of any drugs known to induce or inhibit hepatic drug metabolism (examples of inducers: barbiturates. carbamazepine. phenytoin. glucocorticoids rifampin/rifabutin;examples of inhibitors: antidepressants, cimetidine, diltiazem, erythromycin ketoconazole, MAO inhibitors, neuroleptics, verapamil. quinidine) within 30 days prior to administration of the study medication.
    • Use of an investigational drug or participation in an investigational study within 30 days prior to administration of the study medication.
    • History or presence of any clinically significant gastrointestinal pathology (e.g. chronic diarrhea inflammatory bowel diseases)unresolved gastrointestinal symptoms (e.g.diarrhea, vomiting), liver or kidney disease or other conditions known to interfere with the absorption, distribution, metabolism or excretion of the drug.
    • Any history or presence of clinically significant neurological, endocrinal, cardiovascular,pulmonary, hematologic, immunologic, psychiatric or metabolic disease.
    • Use of prescription medication within 14 days prior to administration of study medication or over-the-counter products (including natural food supplements, vitamins, garlic as supplement) within 7 days prior to administration of study medication, except for topical products without systemic absorption.
    • Use of any tobacco products in the last 6 months.
    • Any food allergy, intolerance, restriction or special diet that, in the opinion of the medical sub investigator, contraindicates the subject's participation in this study.
    • Subjects who have had a depot injection or an implant of any drug 3 months prior to administration of study medication.
    • Donation of plasma (500 mL) within 7 days. Donation or loss of whole blood prior to administration of the study medication as follows:
    • less than 300 niL of whole blood within 30 days or
    • 300 mL to 500 mL of whole blood within 45 days or
    • more than 500 mL of whole blood within 56 days.
    • Subjects with history or known presence of porphyria.

Additional exclusion criteria for females only:

  • Breast-feeding subjects.
  • Positive urine pregnancy test at screening (performed on all females).
  • Female subjects of childbearing potential who have had unprotected sexual intercourse with any non-sterile male partner (i.e. male who has not been sterilized by vasectomy for at least 6 months) within 14 days prior to study drug administration. The acceptable methods of contraception are:

    • Condom + spermicide
    • Diaphragm +spermicide
    • Intrauterine contraceptive device (placed at least 4 weeks prior to study drug administration).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01131702

Locations
Canada, Quebec
Anapharm Inc.
Montreal, Quebec, Canada, G1V 2K8
Sponsors and Collaborators
Dr. Reddy's Laboratories Limited
Investigators
Principal Investigator: Eric Bicrell, M.D. Anapbarm Inc.
  More Information

No publications provided

Responsible Party: Dr. Ramakrishna Bangaru/Assistant Manager, Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier: NCT01131702     History of Changes
Other Study ID Numbers: 02399
Study First Received: May 26, 2010
Last Updated: June 8, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Dr. Reddy's Laboratories Limited:
Bioequivalence
Crossover
Ranitidine

Additional relevant MeSH terms:
Ranitidine
Ranitidine bismuth citrate
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Histamine H2 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 20, 2014