OBJECTIVE To evaluate the bioequivalence of domestic tropisetron preparations and imported tablets.METHODS A total of 24 healthy male volunteers,divided randomly into six groups,were administered with three preparations of tropisetron respectively in an open randomized three cross-over design.A single oral dose of the test and reference preparations was 20 mg.Tropisetron(Trop) concentrations in the serum were determined by high performance liquid chromatography.The pharmacokinetic parameters of tropisetron were obtained using BECS software.RESULTS Tropisetron parameters of the tablets,capsules and the reference preparations were as follows:tmax(1.7±0.4) h;ρmax(36.9±8.9),(36.3±8.9) and(36.1±9.3) μg·L-1;AUC0-tn(443±176),(448±196) and(443±191) μg·h·L-1.The result of statistical analysis showed that there was no significant differences on ρmax,AUC0-tn and tmax among the three preparations.The relative bioavailability of tablets was(102±9)% and the relative bioavailability of capsules was(102±10)%.CONCLUSION The three preparations are bioequivalent.
TNG Jin-lin;WNG Lu;YING Yi;HUNG Yong-ping;ZHOU Shi-wen.
Bioequivalence of Domestic Tropisetron Hydrocloride Tablets,Capsules and Imported Tablets [J]. Chinese Pharmaceutical Journal, 2007, 42(05): 382-385
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