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

This study has been completed.
Sponsor:
Information provided by:
Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier:
NCT01161927
First received: July 13, 2010
Last updated: NA
Last verified: July 2010
History: No changes posted
  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
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 55 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01161927

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

No publications provided

Responsible Party: vice President, Research & Development, Dr. Reddy's Laboratories Limited
ClinicalTrials.gov Identifier: NCT01161927     History of Changes
Other Study ID Numbers: 003-04
Study First Received: July 13, 2010
Last Updated: July 13, 2010
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Nizatidine
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 17, 2014