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Bioequivalence Study of Nizatidine Capsules 300 mg of Dr.Reddy's Laboratories Limited Under Non- Fasting Conditions

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01161927
First Posted: July 14, 2010
Last Update Posted: July 14, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Dr. Reddy's Laboratories Limited
  Purpose
The purpose of this study is to compare experimental evaluation of relative bioavailabilities in healthy, human subjects under non-fasting conditions.

Condition Intervention Phase
Healthy Drug: Nizatidine Drug: Axid Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Two-way Crossover Experimental Evaluation of Relative Bioavailabilities of Two Formulations of Nizatidine 300 mg Capsules in Healthy Human Subjects Under Non-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 ]

Enrollment: 26
Study Start Date: July 2004
Study Completion Date: September 2004
Primary Completion Date: September 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nizatidine
Nizatidine Capsules 300 mg of Dr.Reddy'sLaboratories Limited
Drug: Nizatidine
Nizatidine Capsules 300 mg of Dr.Reddy's Laboratories Limited
Other Name: Axid 300 mg Capsules
Active Comparator: Axid
Axid 300 mg Capsules of Reliant Pharmaceuticals, US
Drug: Axid
Axid 300 mg Capsules of Reliant Pharmaceuticals, US

Detailed Description:
Open label, balanced, randomized, two-treatment, two-period, two sequence, single dose, crossover, comparative oral bioavailability study in healthy, adult, male human subjects under non-fasting conditions.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy males between 18 and 55 years of age (inclusive) living in and around Ahmedabad city of western part of India.
  • Having a Body Mass Index (BMI) ≥ 18.0 kg/m2 (calculated as weight in kg/ height in m2).
  • Have no significant diseases or clinically significant abnormal findings during screening, medical history, physical examination, laboratory evaluations, ECG and X-ray recordings.
  • Able to communicate effectively with study personnel. Able to give consent for participation in the trial

Exclusion Criteria:

  • Known hypersensitivity or idiosyncratic reaction to nizatidine or other related drugs.
  • Any disease or condition which might compromise the haemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal, or any other body system.
  • Ingestion of a medication at any time in 14 days before the start of the study. In any such case subject selection will be at the discretion of the Principal Investigator/Medical expert/co-investigator.
  • Any history or presence of asthma or nasal polyp.
  • A recent history of alcoholism (<2years) or of moderate (180 ml/day) alcohol use.
  • Smokers, who smoke more than 10 cigarettes/day or those who cannot refrain from smoking during study period.
  • The presence of clinically significant abnormal laboratory values during screening.
  • Use of any recreational drugs or history of drug addiction or testing positive in pre-study drug scan.
  • History of psychiatric disorders.
  • A history of difficulty with donating blood.
  • Donations of blood (1 unit or 450 ml) within 90 days prior to receiving the first dose of study medication. Note: Incase the blood loss is ≤ 200 L, subject may be dosed after completion of 60 days of blood donation).
  • A positive hepatitis screen including hepatitis B surface antigen, anti-HCV and anti-HAV antibodies.
  • A positive test result for HIV antibody and/or syphilis.
  • The receipt of an investigational product or participation in a drug research study within a period of 90 days prior to the first dose of study medication (Elimination half-life of the study drug should be taken into consideration for inclusion of the subject in the study). (Note: If subject had participated in a study in which blood loss is ≤200 mL, subject can be dosed after completion of 60 days of previous study).
  • An unusual diet, for whatever reason (eg., low-sodium), for four weeks prior to receiving the study medication and throughout the subjects, participation in the study. In any such case subject will be at the discretion of the Principal Investigator/Medical expert/Co-investigator.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01161927


Sponsors and Collaborators
Dr. Reddy's Laboratories Limited
Investigators
Principal Investigator: Charu Gautam, M.D Lambda Therapeutic Research Ltd
  More Information

Responsible Party: vice President, Research & Development, Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier: NCT01161927     History of Changes
Other Study ID Numbers: 003-04
First Submitted: July 13, 2010
First Posted: July 14, 2010
Last Update Posted: July 14, 2010
Last Verified: July 2010

Keywords provided by Dr. Reddy's Laboratories Limited:
Bioavailability
Nizatidine
Crossover

Additional relevant MeSH terms:
Nizatidine
Anti-Ulcer Agents
Gastrointestinal Agents
Histamine H2 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs