Bioequivalence of Metformin Tablets in Healthy Male Volunteers / 中国药房

ABSTRACT

OJBECTIVETo study the bioequivalence of metformin hydrochloride tablets.METHODS:A single oral dose of1000mg metformin tablet was given to20healthy male volunteers in an open randomized cross-over test.The plasma levels of metformin were determined by HPLC with ultraviolet detection.RESULTS:The pharmacokinetic parameters of tested and metformin tablets were as follows,C max was(2.59?0.62)?g/ml and(2.60?0.62)?g/ml,T max was(2.0?0.5)h and(1.9? 0.5)h,T 1/2ke was(3.01?0.54)h and(2.90?0.50)h,AUC 0～12 was(13.21?3.28)(?g?h)/ml and(12.99?2.98)(?g?h)/ml,AUC 0～∞ was(14.29?3.44)(?g?h)/ml and(13.91?3.23)(?g?h)/ml,respectively.The relative bioavailability of metformin tablet was(101.6?7.9)%.CONCLUSION:This study shows that the two kinds of preparations are bioequiva?lent.