Pharmacokinetics and Bioequivalence of Valsartan Dispersed Tablet in Healthy Volunteers

OBJECTIVE To investigate pharmacokinetic and bioequivalence of valsartan dispersed tablet in healthy volunteers. METHODS Twenty volunteers were randomly divided into 2 groups. A single oral dose of 80 mg of test or reference tablets was delivered to each volunteer in an open crossover test. The plasma concentration of valsartan was determined by HPLC fluorescence detection. Based on the parameters of pharmacokinetic and relative bioavailability, the bioequivalence of valsartan was evaluated. RESULTS Cmax was (2 536±1 293) ng·mL-1and (2 457 ±1 413) ng·mL-1, tmax was (2.5±1.1) h and (2.3±0.7) h , t1/2 was (5.9 ±1.8) h and (5.8 ±1.1) h, AUC0-30 h in 2 groups was (14 984 ±7 155) ng·h·mL-1and (14 390±7 040) ng·h·mL-1 in 2 groups respectively. The relative bioavailability of valsartan dispersed tablet was (115.6 ±52.5)%. CONCLUSION The two preparations of valsartan dispersed tablet and reference tablets are bioequivalent .