The invention provides a
bioequivalence evaluating method for medicines for reducing
blood sugar by using
pharmacodynamics as an index, and relates to a three-cycle three-cross
bioequivalence evaluating method by using
pharmacodynamics parameters of
blood sugar concentration as an evaluating index, wherein the medicines are mainly alpha-
glycosidase inhibitor type medicines. Examines are divided into three groups randomly, and are respectively subjected to
medicine test of reference medicines, contrast medicines and vacancy medicines at the three-cycle experiment stage, and then are subjected to glucose load experiment, and besides, blood samples within 4 hours are collected, and concentration determination results of glucose in serum are recorded as the
blood sugar concentration. Evaluating parameters include the largest blood
sugar concentration difference (
delta Cmax) of the examinees under the condition of being subjected to
medicine test of the reference medicines or the contrast medicines and the vacancy medicines; and the 2-4-hoursblood
sugar concentration-time
area under curve difference (
delta AUC0-n) of the examinee under the condition of being subjected to
medicine test of reference medicines or contrast medicines or vacancy medicine. The judgment standard lies in that the equivalence standard lies in that the 90%
confidence interval of the group geometric mean valueratio of the
delta Cmax to the delta AUC0-n in the evaluating parameters of a
test preparation and the contrast medicines needs to fall in the range of 80%-125%.