Bioequivalence of mifepristone tablets in healthy volunteers

Objective:To establish an HPLC method for determination of pharmacokinetic of mifepristone in human plasma and to evaluate the bioequivalence of two mifepristone tablets in healthy volunteers.Method:In a randomized,crossover and self-control study,18 healthy female volunteers were orally administrated with mifepristone tablets(test sample and reference sample)25 mg.The plasma concentration of mifepristone was determined by HPLC detection.The pharmacokinetic parameters and relative bioavailability were calculated.Results:The main pharmacokinetic parameters of test and reference preparation were as follows:Tmax(0.81± 0.23)and(0.81± 0.23)h;Cmax(849.91± 257.77)and(852.01± 258.26)ng·mL-1;t1/2(29.72± 11.06)and(27.96± 13.35)h;AUC0-120(7259.49± 2256.93)and(7802.63± 4049.20)ng·h·mL-1;AUC0-∞(8635.35±2696.45)and(9354.08±4469.31)μg·h·mL-1,respectively.The relative bioavailability of the test formulation was(104.91± 36.45)%.Conclusion:The method is selective,sensitive and rapid for mifepristone determination.The results showed that the two formulations were bioequivalent.