Bioequivalence of 2 Preparations of Alfuzosin Hydrochloride / 中国药房

ABSTRACT

OBJECTIVE:To compare the bioequivalence between alfuzosin hydrochloride sustained release tablets and the imported alfuzosin common tablets.METHODS:20 health volunteers were assigned to receive oral single dose of 5mg sustained-release and imported tablets of alfuzosin by self crossover way,with alfuzosin concentration in serum determined by HPLC.The pharmacokinetic parameters were calculated;the statistical analysis was carried out and the bioequiavailability was evaluated.RESULTS:The main pharmacokinetic parameters of the sustained-release and the imported tablets of alfuzosin were as followsCmax(28.92? 9.63) ?g? L-1 vs.(32.92? 10.23) ?g? L-1;tmax(2.7? 0.6) h vs.(1.4? 1.0) h;AUC0～ ∞(221.14? 59.46) ?g? h? L-1 vs.(245.68? 67.20) ?g? h? L-1;t1/2(6.68? 0.85) vs.(4.73? 1.22) h;AUC0～ 24(215.20? 49.63) vs.(226.30? 53.60) ?g? h? L-1.The relative bioavailability of alfuzosin hydrochloride sustained release tablets was(92.2? 13.2) %.CONCLUSION:The 2 preparations of alfuzosin are bioequivalent.