Bioequivalence Study of Cetirizine Hydrochloride 10mg Tablets Under Fed Conditions

The study was conducted as an open label, randomized, single-center, single-dose, two-treatment, two-period, crossover bioavailability of the test formulation of cetirizine hydrochloride tablet of Ohm Laboratories Inc. (A subsidiary of Ranbaxy, Inc) containing 10 mg cetirizine hydrochloride study comparing to the marketed product, Zyrtec®, containing 10 mg of cetirizine hydrochloride of Pfizer Labs (Division of Pfizer Inc.), in healthy, adult, human, subjects under fed condition. Safety measures were performed throughout the study and included a physical examination, laboratory evaluation, and measurement of vital signs. A total of 32 subjects were randomized to receive single oral dose of cetirizine hydrochloride 10 mg tablet and 29 subjects completed both the periods of the study.