Bioequivalence study of sinomenone hydrochloride enteric-coated tablets

Objective To establish an HPLC method for determining sinomenone hydrochloride in human plasma,and to investigate the pharmacokinetics and bioequivalence of sinomenone hydrochloride enteric-coated tablets in healthy volunteers.Methods 18 male healthy volunteers were randomized to take a single crossover oral dose of test tablets or reference tablets 40 mg.The concentration of sinomenone hydrochloride in plasma was determined by HPLC.Results The sinomenone hydrochloride main pharmacokinetic parameters of test tablets and reference tablets were as follows:Tmax:(3.4±0.6)h and(3.3±0.4)h;Cmax:(3 435.11±1 101.72)μg·L-1 and(3 312.37±987.50)μg·L-1;T1/2:(1.60±0.31)h and(1.73±0.47)h,AUC(0→36 h):(7 805.88±2 390.66)μg·h·L-1 and(7 459.61±2 641.25)μg·h·L-1;F was(107.30±20.20)%.Conclusions The established method is sensitive,accurate,and the results are reliable.The test tablets are bioequivalent to the reference tablets.