Pharmacokinetics of four preparations of mifepristone in healthy Chinese volunteers

OBJECTIVE To study the pharmacokinetics of four different preparations of mifepristone tablets in healthy female Chinese subjects.METHODS Forty subjects were randomly divided into four groups with ten in each group,given respectively a single oral dose of 75 mg of four different preparations of mifepristone tablets.A series of blood were collected in 96 h.And mifepristone was extracted using ethyl acetate and determined by high performance liquid chromatography.Pharmacokinetics parameters were calculated by Drug and Statistical Software Version 2.0.RESULTS The pharmacokinetics parameters after a single dose of 75 mg four preparations of mifepristone tablets were as follows:Cmax was(1.57±0.36) μg·mL-1,(1.7±0.7) μg·mL-1,(1.4±0.4) μg·mL-1 and(1.6±0.5) μg·mL-1;tmax was(0.70±0.26) h,(1.0±0.6) h,(1.0±0.6) h and(0.80±0.35) h;t1/2 was(26.1±7.6) h,(26.7±5.2) h,(27.1±6.4) h and(28.9±7.4) h;AUC0-96 was(20.3±5.1) μg·mL-1·h,(20.5±6.4) μg·mL-1·h,(18.1±8.7) μg·mL-1·h and(20.7±7.4) μg·mL-1·h respectively.The relative bioavailability of mifepristone tablet B,C,D to mifepristone tablet A was 101.1%、89.4%and 101.8%.CONCLUSION There was no significant difference among the pharmacokinetics of four different preparations of mifepristone tablets in healthy female Chinese subjects.