Study on the bioequivalence of domestic loratadine in healthy volunteers

Objective:To study the bioequivalence and pharmacokinetics of two kinds of loratadine tablets in 20 healthy volunteers.Methods:An oral dose of 20mg of test or reference loratadine tablets was given according to a randomized 2-way cross-over design,blood samples were withdrawn up to 12 hours past administration,and plasma concentration of loratadine was determined by HPLC method.Results:The peak plasma levels (C max ) of loratadine test drug and reference drug were 8.59±6.70 or 9.59±8.22ng/ml respectively. The peak time (T max ) were 1.08±0.41 or 1.21±0.28h respectively,and AUC 0-t were 27.29±25.54 or 27.12±20.64ng·h/ml respectively.Conclusion:The result of statistic analysis and tow one-sided test suggest that the domestic loratadine talbet is bioequivalent to the imported tablet.The relative bioavailability of domestic loratadine tablets is 100.63%±14.27%.