Pharmacokinetics and Bioequivalence of 2 kinds of Metformin Hydrochloride Tablet in Human Body

OBJECTIVE:To compare the bioequivalence of two kinds of metformin hydrochloride tablets.METHODS: Blood drug levels of 18 Chinese healthy male volunteers were determined by HPLC after receiving single oral dose of 2 kinds of metformin hydrochloride 1g in a randomized crossover protocol,pharmacokinetic parameters and relative bioavailability were analyzed computed by 3p97 program.RESULTS:Pharmacokinetic parameters of sample vs.reference substance were stated as follows:tmax(2.14±0.41)and(2.25±0.43)h,Cmax(3.86±1.19) and (3.86±1.34)mg/L,t1/2(3.18±0.93) and(3.32±0.67)h,AUC0→t(19.30±5.45)and(19.82±5.67)(mg·h)/L,AUC0→∞(21.07±5.67)and(21.68±5.95)(mg·h)/L.The relative bioavailability of F0→t and F0→∞ of the sample were(98.3±12.2)% and(98.1±12.0)%,respectively.CONCLUSION:2 preparations were bioequivalent.