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

NCT01161940 | Completed Phase 1 DMC

• 1 other identifier: 090-04
• Study Type: interventional
• Target: 26
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Healthy

Keywords

Bioavailability; Nizatidine; Crossover

Outcome Measures

Primary Outcomes (1)

• Bioequivalence based on Cmax and AUC parameters

  3 Months

Study Arms (2)

Nizatidine

EXPERIMENTAL

Nizatidine Capsules 300 mg of Dr.Reddy'sLaboratories Limited

Drug: Nizatidine

Axid

ACTIVE COMPARATOR

Axid 300 mg Capsules of Reliant Pharmaceuticals, US

Drug: Axid

Interventions

Nizatidine DRUG

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

Also known as: Axid 300 mg Capsules

Nizatidine

Axid DRUG

Axid 300 mg Capsules of Reliant Pharmaceuticals, US

Axid

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Dr. Reddy's Laboratories Limited: lead

MeSH Terms

Interventions

Nizatidine

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Charu Gautam, M.D

  Lambda Therapeutic Research Ltd.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 13, 2010
• First Posted: July 14, 2010
• Study Start: July 1, 2004
• Primary Completion: September 1, 2004
• Study Completion: September 1, 2004
• Last Updated: July 14, 2010

Record last verified: 2010-07