Bioequivalence of oral sertraline hydrochloride tablets and dispersible tabletsin healthy volunteers

Objective To study the bioavailability and bioequivalence of the tested and reference sertraline hydrochloride(tablets and dispersible tablets) in healthy male volunteers.Methods According to the 3-way crossover design,each volunteer was given orally 50 mg sertraline hydrochloride.The plasma concentrations were determined by LC/MS/MS.Pharmacokinetic parameters were obtained using BAPP 2.2 program.Results Cmax were(14.10±6.49) μg/ml,(14.17±6.02) μg/ml and(14.51±6.27) μg/ml,Tmax were(5.22±1.17) h,(5.11±1.68) h and(4.72 ± 1.18) h,T1/2 were(29.92±7.43) h,(27.55±6.89) h and(29.04±7.52) h,AUC0-tn were(457.86±236.28) μg/(ml·h),(452.62±259.41) μg/(ml·h) and(452.49±275.10) μg/(ml·h),AUC0-∞ were(502.95±276.04) μg/(ml·h),(493.11±299.28) μg/(ml·h) and(502.59±324.23) μg/(ml·h),respectively.The relative bioavailability was(105.22±21.85)% and(103.26±19.00)%.The data of the reference and tested drugs were up to the standard of bioequivalence as shown by F test.Conclusions Two samples of sertraline hydrochloride tablets and one sample of dispersible tablet made in two different pharmaceutical companies are bioequivalent.