Pharmacokinetics of Balofloxacin Tablets in Chinese Healthy Volunteers / 中国药房

ABSTRACT

OBJECTIVE:To study the pharmacokinetics of balofloxacin tablets in Chinese healthy volunteers.METHODS:A single dose of 100 or 200 mg balofloxacin tablets were given to 12 healthy volunteers in a randomized crossover design.Concentrations of balofloxacin in plasma and urine were determined by HPLC with data processed by DAS(drug and statistics)software.RESULTS:After administration of balofloxacin 100 mg and 200 mg,the Cmax were(0.970?0.245)?g?mL-1 and(1.849?0.466)?g?mL-1;the tmax were(1.25?1.10)h and(1.24?0.81)h;the t1/2 were(7.14?1.01)h and(7.11?0.72)h;the AUC0～36 were(7.309?1.368)?g?h?mL-1 and(15.214?1.727)?g?h?mL-1;AUC0～∞ were(7.531?1.386)?g?h?mL-1 and(15.695?1.762)?g?h?mL-1;the accumulative eliminating rates within 36 h in urine were(64.47?11.56)% and(63.24?11.93)%,respectively.CONCLUSION:The pharmacokinetics of balofloxacin in healthy volunteer after oral administration was characterized by high peak concentration and long half life.The method is sensitive,accurate,reliable and specific,and can satisfy the requirements for pharmaceutical study.