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

A Two-way Crossover Experimental Evaluation of Relative Bioavailabilities of Two Formulations of Nizatidine 300 mg Capsules in Healthy Human Subjects Under Fasting Conditions

This is a bioequivalence study of nizatidine Capsules 300 mg of Dr.Reddy's Laboratories Limited under fasting conditions

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Nizatidine; Drug: Axid

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 fasting conditions.

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nizatidine; Nizatidine Capsules 300 mg of Dr.Reddy'sLaboratories Limited	Drug: Nizatidine; Nizatidine Capsules 300 mg of Dr.Reddy's Laboratories Limited; Other Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Bioequivalence based on Cmax and AUC parameters	3 Months

Collaborators and Investigators

• Sponsor: Dr. Reddy's Laboratories Limited
• Investigators: Principal Investigator: Charu Gautam, M.D, Lambda Therapeutic Research Ltd.

Study record dates

Study Major Dates

• Study Start: July 1, 2004
• Primary Completion (Actual): September 1, 2004
• Study Completion (Actual): September 1, 2004

Study Registration Dates

• First Submitted: July 13, 2010
• First Submitted That Met QC Criteria: July 13, 2010
• First Posted (Estimate): July 14, 2010

Study Record Updates

• Last Update Posted (Estimate): July 14, 2010
• Last Update Submitted That Met QC Criteria: July 13, 2010
• Last Verified: July 1, 2010

More Information

Terms related to this study

• Keywords: Crossover; Bioavailability; Nizatidine
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Anti-Ulcer Agents; Histamine Antagonists; Histamine Agents; Histamine H2 Antagonists; Nizatidine
• Other Study ID Numbers: 090-04