Cetirizine Hydrochloride Tablets, 10 mg Bioequivalence Study of Dr.Reddy's Under Fasting Condition

NCT01064102 | Completed Phase 1

• 1 other identifier: 007-06
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

A Two Way, Open Label, Single Dose, Cross Over, Experimental Evaluation of Relative Bioavailabilities of Two Formulations of Cetirizine Hydrochloride Tablets 10 mg of Dr. Reddys laboratories with Zyrtec 10 mg of Pfizer labs in Healthy Adult Human Male Subjects Under Fasting Conditions.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Bio-equivalence study of Dr Reddys Laboratories Cetirizine Hydrochloride Tablets 10 mg

  2 months

Study Arms (2)

Cetirizine

EXPERIMENTAL

Cetirizine Hydrochloride Tablets 10 mg of Dr. Reddys Laboratories Limited

Drug: Cetirizine Hydrochloride

Zyrtec

ACTIVE COMPARATOR

Zyrtec Tablets 10 mg of Pfizer Labs

Drug: Cetirizine Hydrochloride

Interventions

Cetirizine Hydrochloride DRUG

Cetirizine Hydrochloride Tablets 10 mg

Also known as: Zyrtec Tablets 10 mg

Cetirizine; Zyrtec

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy males between 18 and 45 years of age (both inclusive) living in and around Ahmedabad city of western part of India.
• Having a Body Mass Index (BMI) between 18.5 and 24.9 {both inclusive), calculated as weight in kg/height in m2
• Not having any significant diseases or clinically significant abnormal findings during screening, medical history, physical examination, laboratory evaluations, ECG and X-ray recordings.
• Able to comply with the study procedures, in the opinion of the investigator.
• Able to give written consent for participation in the trial.

You may not qualify if:

• Known hypersensitivity or idiosyncratic reaction to cetirizine or any other related drugs.
• Any disease or condition which might compromise the hemopoietic, renal, hepatic, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system.
• Use of any medicine within 14 days prior to start of the study. In any such case subject selection will be at the discretion of the Principal investigator / Medical expert
• Any history or presence of asthma (including aspirin induced asthma) or nasal polyp or NSAIDs induced urticaria.
• A recent history of alcoholism (\<2 years) or of moderate (180 mL/day) alcohol use, or consumption of alcohol within 48 hr prior to receiving IP.
• Smokers, who smoke more than 10 cigarettes / day or inability to abstain from smoking during the study.
• 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 scans.
• History of psychiatric disorders.
• A history of difficulty in donating blood.
• Donation of blood (1 unit or 350 mL) within 90 days prior to receiving the first dose of IP.
• Note: In case, the blood loss was ≤200 mL; subject can be dosed 60 days after the 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.
• Note: If subject had participated in a study in which blood loss was ≤200 mL, subject can be dosed after completion of 60 days after the last sample of the previous study.

Sponsors & Collaborators

• Dr. Reddy's Laboratories Limited: lead

MeSH Terms

Interventions

Cetirizine

Intervention Hierarchy (Ancestors)

Hydroxyzine; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Charu Gautam, MD

  Lambda Therapeutic Research Ltd, Ahmedabad - 380 054, Gujarat, INDIA

  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: February 4, 2010
• First Posted: February 8, 2010
• Study Start: January 1, 2006
• Primary Completion: January 1, 2006
• Study Completion: February 1, 2006
• Last Updated: February 8, 2010

Record last verified: 2010-02