Abstract
Objective:To evaluate the pharmacokinetics and relative bioavailability of domestic and imported fluconazole capsules in 20healthy male volunteers.Methods:A single oral dose of 150mg test(domestic)and reference(imported)fluconazole preparations were given respectively to the volunteers according to randomized two-way crossover study design.The washout period was two weeks.The plasma concentration of fluconazole was determined by HPLC method.Results:The main pharmacokinetic parameters of the test and reference preparations were as follows:t1/2(31.09±5.49)and(32.57±6.33)h;tmax(1.05±0.63)and(1.54±1.14)h;cmax(3.90±0.43)and(3.73±0.67)μg/ml;AUC0-120(128.39±15.74)and(127.30± 25.64)μg.h.ml-1;AUC0-∞(139.02±18.12)and(138.48±29.90)μg.h.ml-1,respectively.There were no significant differences in main pharmacokinetic parameters between the test and reference preparations(P 0.05).The relative bioavailability of the test preparation was(102.25±9.29)%.Conclusion:The results of statistical analysis showed that the two formulations were bioequivalent.
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