Pharmacokinetics and Bioequivalence of 3 Kinds of Sparfloxacin Preparations in Healthy Volunteers

OBJECTIVE:To compare the pharmacokinetics of 3 kinds of sparfloxacin preparations in healthy volunteers,and to evaluate the bioequivalence of 3 kinds of preparations.METHODS:A total of 24 healthy volunteers received a single dose of Sparfloxacin capsules 400 mg (test preparation 1),Sparfloxacin tablets 400 mg (test preparation 2) or Sparfloxacin capsules 400 mg (reference preparation) respectively.The plasma concentrations of sparfloxacin were determined by HPLC.The pharmacokinetic parameters and bioequivalence of sparfloxacin were calculated using DAS2.1.1 software.RESULTS:The main pharmacokinetic parameters of test preparation 1,test preparation 2 and reference preparation were as follows:cmax(1.614±0.572)μg·mL-1,(1.760±0.498) μg·mL-1,(1.609±0.419)μg·mL-1;tmax(4.563±2.188) h,(4.708±2.116) h,(4.542±2.226) h;t1/2(21.890±5.150)h,(21.954±6.808)h,(23.336±5.762)h;AUC0～72h(42.809±12.684)μg·h·mL-1,(44.559±10.787)μg·h·mL-1,(43.193±8.757)μg·h·mL-1;AUC0～∞(48.149±14.678)μg·h·mL-1,(50.697±14.812)μg·h·mL-1,(49.588±11.484)μg·h·mL-1.F0～72h of test preparation 1 and test preparation 2 were(104.2±25.9)% and (96.9±20.7)%.There was no significant difference in cmax,tmax,AUC0～72h and AUC0～∞ among 3 kinds of preparations.CONCLUSION:Sparfloxacin capsules,Sparfloxacin tablets and reference preparation are bioequivalent.