Study on Bioequivalence of Domestic Metformin Hydrochloride Tablets / 中国药房

ABSTRACT

OBJECTIVE: To study the bioequivalence of Bei Shi metformin hydrochloride(METBS) and Bo Lai metformin hyddrochloride tablets(METBL) in healthy volunteers.METHODS: A single oral dose of 1 OOOmg METBS and METBL were given to 20 healthy volunteers in an open randomized crossover study.Drug concentrations in serum were determined by HPLC.The pharmacokinetic parameters were calculated and analysed by 3p97 program with a statistic analysis of ANOVA, two-one-side t - test and confidence zone of (la-2a)% .RESULTS: The Tmax, Cmax and AUC(10-24) of METBS tables and METBL tables were (2.42 + 1.03) h and (2.50+1.08) h, (2.22+0.69) ug/ml and (2.1210.47) ug/ml, (16.491 5.70) mg/ (h . L) and (16.98 + 6.38) mg/ (h . L), respectively.There were no significant differences between the two formulations in the Tmax, Cmax and AUC (0-24).CONCLUSION: The mean relative bioavailability of METBS tables was(98.29 + 11.98) % compared with METBL tables.The RESULTS: suggest that two products are bioequivalent.