Study on the Pharmacokinetics and Bioavailability of Loratadine Tablets in Healthy Volenteers

OBJECTIVE: To study the pharmacokinetics and bioequivdent ofloratadine in healthy Volunteers. METHODS:A single oral dose 40mg loratadine ofreference or test preparations was given to healthy male volunteers according toan open randomized crossover study.The plasma concentrations of loratadine weredetermined by a RP HPLC method. The pharmacokinetic parameters and biovailabilityof test preparation were compared with reference preparation. RESULTS: The mainpharmacokinetic parameters of the reference and the test preparation were as follows:Cmax were 34.9±16.6μg.L-1and 33.5±l7.4μg.L-1; tmax were 0.76±0.24h and 0.75±0.26h;t(1/2)were l.63±0.48h and l.73±0.49h;AUC0-tn were 53.7±25.9μg.h.L-1 and48.8±2l.0μg.h.L-1; AUC0→∞were 58.5±28.0μg.h.L-1 and 54.6±23.8μg.h.L-1, Therelative bioavailability of reference to test preparation was 94.5 %±l4.5 %.CONCLUSION: The results of statistics analysis showed that the referencepreparation and the test preparation were bioequivalent.