Pharmacokinetic Characteristics Study of Potassium Bismuth Citrate Capsules in Healthy Chinese Volunteers
OBJECTIVE The objective of this study is to investigate the pharmacokinetic traits of bismuth potassium citrate capsules taken by healthy Chinese volunteers on a single fasting occasion.METHODS The study utilized a single-center,randomized,open,single-dose,two-preparation,two-period,two-sequence crossover design.The concentration of bismuth in plasma was determined by ICP-MS,and Phoenix WinNonlin 8.2 software wasused to apply the non-atrioventricular model(NCA module)to calculate the pharmacokinetic parameters.RESULTS Twenty volunteers were enrolled.The main pharmacokinetic parameters of bismuth potassium citrate capsules and bismuth potassium citrate tablets were as follows:Tmax were 0.42(0.33,0.67)and 0.33(0.17,0.67)h,Cmax were(33.099±43.981)and(86.491±81.253)ng·mL-1,AUC0-t were(105.0±96.8)and(212.8±209.8)h·ng·mL1,AUC0-∞ were(141.6±107.2)and(235.0±216.0)h·ng·mL-1,t1/2 were(13.09±2.93)and(11.75±7.68)h,Vd/F were(25 742 420.5±14 564 239.2)and(14 486 591.6±9 908 940.9)mL,and CL/F were(1 389 579.6±855 227.0)and(1 019 878.2±754 084.1)mL·h-1.CONCLUSION Following a single fasting oral administration of bismuth potassium citrate capsules in healthy Chinese volunteers,bismuth is rapidly released and absorbed locally in the stomach,but only trace amounts are absorbed.Released locally and absorbed rapidly in the stomach,but absorption is minimal,lower than that of bismuth potassium citrate tablets.The plasma concentration of bismuth is below the levels that might cause toxic reactions,showing good safety and tolerance.
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