Pharmacokinetic and Relative Bioavailability of Losartan Potassium Tablet in Chinese Healthy Volunteers

OBJECTIVE To evaluate the bioequivalence of test and reference losartan potassium tablets in healthy volunteers.METHODS A single oral dose of 50 mg test or reference preparation was administrated to 20 healthy volunteers in a randomized cross-over study.The concentration of losartan and E-3174 in human plasma were determined by HPLC-MS/MS.The pharmacokinetic parameters were calculated by DAS 2.1.1 analysis software.RESULTS For losartan test and reference formulations,the unchanged losartan ρmax were(207.50±68.14),(187.23±89.92) μg·L-1,tmax were(1.69±1.70),(1.53±0.76) h,AUC0-12 h were(457.79±126.46),(442.08±137.48) μg·h·L-1,t1/2 were(2.09±0.59),(2.01±0.33) h,respectively.ρmax of E-3174 were(642.05±280.08),(659.91±295.72)μg·L-1,tmax were(4.10±1.86),(4.23±1.69) h,AUC0-36 h were(4 702.39±1 803.18),(4 703.28±1 959.33)μg·h·L-1,t1/2 were(4.82±0.84),(5.13±1.94) h,respectively.CONCLUSION The analysis of variance showed no significant difference on the pharmacokinetic parameters.The test formulation was considered bioequivalent to the reference formulations.