Studies on bioequivalence of losartan potassium capsule and tablet in healthy volunteers

Objective: To evaluate the pharmacokinetics and the bioequivalence between losartan potassium capsule and tablet in healthy volunteers.Methods: It was designed as randomized,two-way crossover study with 1 week washout interval,and blood samples were collected after administration with a single oral dose 50 mg of test and reference preparation in 20 healthy male volunteers,the plasma concentrations of losartan and E-3174 were determined by LC-MS/MS.The pharmacokinetics parameters were calculated and statistically analyzed by DAS2.0 software.Results: The pharmacokinetic parameters of losartan and E-3174 of test and reference preparation were as follows: for losartan,Cmaxwere(183.83±91.30),(176.45±93.97) μg.L-1;AUC0-twere(333.18±105.00),(323.75±101.92) μg.h.L-1;AUC0-∞ were(344.88±104.15),(341.32±106.13) μg.h.L-1;t1/2 were(1.84±0.52),(1.99±0.60) h;tmax were(0.70±0.22),(0.98±0.62) h,respectively.For E-3174,Cmax were(344.85±114.33),(329.95±106.42) μg.L-1;AUC0-t were(2 445.09±608.97),(2 332.54±564.72) μg.h.L-1;AUC0-∞ were(2 503.45±612.62),(2 390.92±567.03) μg.h.L-1;t1/2were(4.17±0.49),(4.13±0.66) h;tmax were(3.14±0.72),(3.39±0.96) h,respectively.The relative bioavailability of losartan and E-3174 of the test preparation were(104.9±20.7) % and(105.2±12.1)%.Conclusion: The losartan potassium capsule and tablet were bioequivalent.