Overview

Bioequivalence Study of Cetirizine Hydrochloride 10mg Tablets Under Fed Conditions

Status:
Completed
Trial end date:
2005-06-01
Target enrollment:
0
Participant gender:
All
Summary
An open label, randomized, single-center, single-dose, two-treatment, two-period, crossover bioavailability study comparing Cetirizine Hydrochloride 10 mg tablet of Ohm Laboratories Inc. (A subsidiary of Ranbaxy, Inc) with Zyrtec® Cetirizine Hydrochloride, 10 mg tablet of Pfizer Labs (Division of Pfizer Inc.) in healthy, adult, human subjects under fed condition
Phase:
N/A
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Ranbaxy Laboratories Limited
Collaborator:
Ohm Laboratories, Inc.
Treatments:
Cetirizine
Criteria
Inclusion Criteria:

- - Aged 18-50 years.

- Were within 18 to 29.9 kilograms/m2 per the BMI (Determination of Body Mass Index).

- Had voluntarily given written informed consent to participate in this study.

- Were of normal health as determined by medical history and physical examination of the
subjects performed within 30 days prior to the commencement of the study.

- Blood chemistry, hematology, and urinalysis tests performed within 30 days prior to
the start of the study must be within clinically acceptable limits upon evaluation by
the Investigator.

- Subjects must have screening and check-in (each period) blood pressure and pulse rate
within the protocol specified ranges.

- If female and of childbearing potential, the subject was counseled on the importance
of not becoming pregnant before or during the study, and the subject had a negative
pregnancy test at the pre-treatment visit.

Exclusion Criteria:

- - History of clinically significant organ-system (cardiovascular, neurological,
hepatic, hematopoietic, pulmonary, endocrine, or gastrointestinal) disorders, or
ongoing infectious diseases.

- history of alcohol abuse or drug addiction requiring treatment within the last 12
months.

- Presence or history of renal impairment or chronic liver disease.

- History of jaundice (yellowing of the skin or whites of the eyes).

- Participation in an investigationaldrug study or donation of blood within 30 days
prior to the start of the study.

- Known allergy or sensitivity to cetirizine (Zyrtec®), or to related drugs such as
hydroxyzine (Vistaril® or Ataraxl®).

- Prescription drug use (excluding hormonal contraceptives) within 14 days prior to drug
administration, each period. Subject is taking macrolide antibiotics, such as
erythromycin, azithromicin, ketoconazole, or related drugs.

- Ingestion of grapefruit juice or grapefruit-containg products within 72 hours prio to
drug administration, each period.

- Alcohol consumption 24 hours prior to drug administration, each period.

- Caffeine or xanthine consumption for at least 10 hours prior to drug administration,
each period.

- Female subjects who are pregnant or nursing.

- Positive HIV 1, Hepatitis B surface antigen, and urine screen for drugs of abuse
within 30 days prior to the start of the study.