Study on bioequivalence of three kinds of loratadine preparations

AIM: To evaluate the bioequivalence of three kinds of loratadine preparations in healthy volunteers. METHODS: A single oral dose of loratadine of reference or test preparations 40 mg was given to healthy male volunteers according to an open randomized three cross-over design. The plasma concentrations of loratadine were determined by a RP-HPLC method. The pharmacokinetic parameters and bioavailability of two test prepartions were compared with reference preparation. RESULTS: The main pharmacokinetic parameters were as follows: T_ max were (1.0±s 0.5), (1.0±0.4) and (0.9±0.3)h; C_ max were (36±15), (37±16) and (36±15) μg·L -1; T_ 1/2 were (3.5±1.0), (3.6±0.8) and (3.7±1.0)h; AUC_ 0-12 were (109±46), (110±51), and (108±46) μg·h·L -1; AUC_ 0～∞ were ( 118±50), (120±54), and (119±51)μg·h·L -1; The relative bioavailability of two test preparations reference preparation were (101±12)% and (101±14)%. CONCLUSION: The two test preparations and the reference preparation are bioequivalent.