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

NCT ID: NCT01161940

Last Updated: 2010-07-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-07-31
• Study Completion Date: 2004-09-30

Brief Summary

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

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Nizatidine

Nizatidine Capsules 300 mg of Dr.Reddy'sLaboratories Limited

Group Type: EXPERIMENTAL

Nizatidine

Intervention Type: DRUG

Nizatidine Capsules 300 mg of Dr.Reddy's Laboratories Limited

Axid

Axid 300 mg Capsules of Reliant Pharmaceuticals, US

Group Type: ACTIVE_COMPARATOR

Axid

Intervention Type: DRUG

Axid 300 mg Capsules of Reliant Pharmaceuticals, US

Interventions

Nizatidine

Nizatidine Capsules 300 mg of Dr.Reddy's Laboratories Limited

Intervention Type: DRUG

Axid

Axid 300 mg Capsules of Reliant Pharmaceuticals, US

Intervention Type: DRUG

Other Intervention Names

Axid 300 mg Capsules

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Dr. Reddy's Laboratories Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Dr. Reddy's Laboratories Limited

Principal Investigators

Charu Gautam, M.D

Role: PRINCIPAL_INVESTIGATOR

Lambda Therapeutic Research Ltd.

Other Identifiers

090-04

Identifier Type: -

Identifier Source: org_study_id