Abstract��
OBJECTIVE To study the bioequivalence of metformin hydrochloride tablets in healthy volunteers.METHODS A single oral dose(1 000 mg) and multiple oral doses(1 000 mg��d-1��7 d) of reference or test metformin hydrochloride preparations were given to 20 healthy male volunteers according to an open randomized crossover study.The plasma concentrations of metformin hydrochloride were determined by RP-HPLC method.The pharmacokinetic parameters and bioavailability of test preparation were compared with reference preparation.RESULTS The main pharmacokinetic parameters of the test preparation and the reference preparation were as follows,single dose(SD): ��max(2.329��0.486) and(2.308��0.502) mg��L-1;tmax(3.700��0.571) and(3.600��0.940)h;t1/2(7.484��2.612) and(7.724��2.799)h;AUC0��t(13.387��3.394) and(13.589��2.917) mg��h��L-1;AUC0����(18.575��3.841) and(19.069��3.792) mg��h��L-1.The relative bioavailability of the test to reference preparation was(98.10��8.90)%.Multiple doses(MD): ��max(1.876��0.545) and(2.111��0.630) mg��L-1;��min(0.212��0.047) and(0.227��0.054)mg��L-1;tmax(4.100��0.912) and(3.750��0.716)h;t1/2((11.477��3.851))and(13.529��4.067) h;AUCss(15.137��2.749) and(15.855��3.322) mg��h��L-1;��av(0.631��0.114) and((0.661��0.138)) mg��L-1;DF(2.609��0.644)% and(2.812��0.645)%,respectively.The relative bioavailability of test to reference preparation was(98.00��22.7)%.CONCLUSION The results of statistic analysis show that the reference preparation and the test preparation are bioequivalent.
2006, Vol. 41 
