Bioequivalent study on roxithromycin tablets in healthy volunteers

Objective To evaluate the relative bioavailability and bioequivalence of test roxithromycin tablets compared with reference roxithromycin tablets.Methods Eighteen male healthy volunteers orally took fl single dose of 300 mg tablets in a randomized cross-over on an empty stomach.The plasma concentractions of roxithromycin were determined by HPLC-MS method.Results The main pharmacokinetic parameters of the tested and reference agents were as follows:Tmax was(1.78±0.67)h and(1.92±0.83)h,respectively;Cmax was(10.85±2.70)μg/ml and(10.54±2.50)μg/ml,respectively;T1/2 was(11.40±2.51)h and(11.81±4.21)h,respectively;AUC(0-t)was(104.9±41.2)μg·h·ml-1and(106.1±37.2)μgh·ml-1,respectively;AUGo(0-∞)was(111.1±44.9)μg·h·ml-1and(113.5±40.3)μg·h·ml-1,respectively.There was no significant difference in main pharmaeokinetic parameters between two preparations.The relative bioavailability of roxithromyein tablets was(98.8±21.12)%.Conclusions Two preperations of roxithromycin tablets are bioequivalent in healthy human. Key words: Roxithromycin tablets; Bioequivailability; Bioequivalenee; HPLC-MS