Pharmacokinetics of Prulifloxacin Capsules in Healthy Volunteers / 中国药房

ABSTRACT

OBJECTIVE:To study the pharmacokinetics of prulifloxacin capsules in Chinese healthy volunteers after single and multiple oral administration of prulifloxacin capsules.METHODS:A total of 12 healthy adult subjects were randomly grouped by 3? 3 Latin square,who were assigned to receive oral single dose of 132,264 and 528mg prulifloxacin capsules and multiple doses of 264mg prulifloxacin capsule for 6 days in succession.The blood concentration of NM394-the metabolite of Prulifloxacin was determined by HPLC at different time after oral administration of Prulifloxacin.The simulation and fitting,and computation of parameters were performed using DAS ver1.0 software.RESULTS:All 12 subjects had completed single oral administration test,with no adverse drug reactions appeared during the test.No prulifloxacin but its metabolite-NM394 was identified in the blood sample of subjects.The high,medium and low dosage groups were all fitted two-compartment model.The pharmacokinetics fitted first order kinetics process without gender difference.There was no accumulation and pharmacokinetic parameters change after multiple oral administration of prulifloxacin,suggesting prulifloxacin had no self-enzyme inhibition or induction.CONCLUSION:The established method is sensitive,accurate,reliable and specific,and it can meet the requirement of clinical pharmacokinetic trial.Its parameters are in line with literature reported abroad,with no gender difference among Chinese adults.