Bioequivalence Study of Cetirizine Hydrochloride 10mg Tablets Under Fasting Conditions

• Status: Completed
• Trial end date: 2004-12-01
• 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 fasting condition

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Ranbaxy Laboratories Limited
• 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.