Study on pharmacokinetics and bioequivalence of Metformin Hydrochloride Tablet in Human

OBJECTIVE To study the pharmacokinetics and bioequivalence of Metformin Hydrochloride Tablet in human.METHODS In a randomized and cross-over study,18 healthy volunteers were divided into two groups and orally given 1000mg Metformin Hydrochloride Tablet(test or reference).A sensitive and rapid HPLC method was developed to determine the metformin plasma concentration.The plasma concentration-time curves and the bioequivalence of reference and test preparation were analyzed by DAS1.0 software.RESULTS The main pharmacokinetic parameters were as follows,Cmax(2.00±0.37)and(1.96±0.42)μg·mL-1,AUC0~24(10.71±1.42)and(10.62±1.32)μg·mL-1·h,AUC0~∞(12.00±1.51)and(11.94±1.46)μg·mL-1·h,t1/2(7.97±0.71)and(8.10±0.60)h,Tmax(1.89±0.21)and(1.89±0.21)h.The relative bioavailability of Metformin Hydrochloride Tablet test was(100.97±7.73)%.CONCLUSION The main pharmacokinetic parameters(Cmax,AUC0~24,AUC0~∞(and t1/2)of metformin hydrochloride tablet test and reference were no statistically significant differences.The reference and test preparation were bioequivalent.