OBJECTIVE To evaluate the bioequivalence of domestic finasteride tablet and imported tablet. METHODS A single oral dose of 10 mg domestic tablet or imported tablet was given to 20 healthy volunteers in a randomized crossover study. The concentrations of finasteride were determined by HPLC method. RESULTS The main pharmacokinetic parameters of the two products were as follows:AUQ0-24(840.63±140.84) and (847.51±166.96) ng-h-mL-1, cmax(117.17±19.74) and (117.43±18.06) ng·mL-1, tmax(1.88±0.48) and (1.95±0.43)h,respectively. The relative bioavailability of domestic tablet to imported tablet was (100.73土15.27)%. There were no significant differences on the pharmacokinetic parameters between the two preparations(P>0.05). CONCLUSION The results demonstrated that the two preparations were bioequivalent.
FU Jun;LI Yn-yn;ZHNG Hui-jie;XU Wen-wei;XIONG Yu-qing.
Studies on the pharmacokinetics and bioquivalence of domestic finasteride tablet in healthy volunteers[J]. Chinese Pharmaceutical Journal, 2004, 39(07): 533-535
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