Overview

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

Status:
Completed
Trial end date:
2006-02-01
Target enrollment:
0
Participant gender:
Male
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Dr. Reddy's Laboratories Limited
Treatments:
Cetirizine
Criteria
Inclusion Criteria:

1. Healthy males between 18 and 45 years of age (both inclusive) living in and around
Ahmedabad city of western part of India.

2. Having a Body Mass Index (BMI) between 18.5 and 24.9 {both inclusive), calculated as
weight in kg/height in m2

3. Not having any significant diseases or clinically significant abnormal findings during
screening, medical history, physical examination, laboratory evaluations, ECG and
X-ray recordings.

4. Able to comply with the study procedures, in the opinion of the investigator.

5. Able to give written consent for participation in the trial.

Exclusion Criteria:

1. Known hypersensitivity or idiosyncratic reaction to cetirizine or any other related
drugs.

2. Any disease or condition which might compromise the hemopoietic, renal, hepatic,
endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological,
gastrointestinal or any other body system.

3. 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

4. Any history or presence of asthma (including aspirin induced asthma) or nasal polyp or
NSAIDs induced urticaria.

5. 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.

6. Smokers, who smoke more than 10 cigarettes / day or inability to abstain from smoking
during the study.

7. The presence of clinically significant abnormal laboratory values during screening.

8. Use of any recreational drugs or history of drug addiction or testing positive in
pre-study drug scans.

9. History of psychiatric disorders.

10. A history of difficulty in donating blood.

11. 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.

12. A positive hepatitis screen including hepatitis B surface antigen, Anti- HCV and Anti
HAV antibodies.

13. A positive test result for HIV antibody and/or syphilis.

14. The receipt of an investigational drug or product, or participation in a drug research
study within a period of 90 days prior to the first dose of IP (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 was ≤200 mL, subject
can be dosed after completion of 60 days after the last sample of the previous study.

15. An unusual diet, for whatever reason (e.g. low-sodium), for four weeks prior to
receiving the IP and throughout the subjects participation in the study. In any such
case subject selection will be at the discretion of the Principal lnvestigator/Medical
expert.