Bioequivalence of Metformin Tablets in Healthy Male Volunteers

OJBECTIVE:To 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)μg/ml and(2.60±0.62)μg/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)(μg·h)/ml and(12.99±2.98)(μg·h)/ml,AUC 0～∞ was(14.29±3.44)(μg·h)/ml and(13.91±3.23)(μg·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 bioequivaˉlent.