Bioequivalence of letrozole tablet in Chinese healthy volunteers

Objective To evaluate the pharmacokinetics and relative bioavailability of letrozole tablet in healthy volunteers.Methods A single oral doses of 2.5 mg letrozole tablet(reference and test) were given to 24 healthy volunteers according to an open randomized crossover design.The concentrations of reference and test tablets in plasma were determined by LC-MS/MS.Results The pharmacokinetic parameters of test drug and reference drug were as follows: Cmax were(24.48±5.72),(26.17±5.55) ng·mL-1,Tmax were(1.88±1.04),(1.98±1.26) h,t1/2 were(60.04±34.45),(55.31±23.05) h,AUC0-t were(1749.08±859.64),(1793.65±808.62) ng·h·mL-1,AUC0-∞ were(1949.90±1254.63),(1918.28±955.15) ng·h·mL-1,respectively.The relative bioavailability was(97.94±13.35)%.Conclusion The test preparation was bioequivalent to the referent preparation.