Bioequivalence Study of Cetirizine Hydrochloride 10mg Tablets Under Fasting Conditions

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.