A Single Dose Pharmacokinetics of Gatifloxacin Mehanesulfanae Injection in Chinese Healthy Volunteers

OBJEIVE: To investigate the pharmacokinetics of gatifloxacin mehanesulfanae after intravenous in single dose in Chinese healthy volunteers. METHODS: The protocol was designed according to good clinical praice(GCP) principle. The drug concentration of plasma sample from the 9 volunteers after intravenous 100, 200and400mg gatifloxacin mehanesulfanae was determined by HPLC method. The pharmacokinetic parameters were calculated by 3P97 software. RESULTS: The plasma concentration time curve fits two compartment model after intravenous gatifloxacin mehanesulfanae 100, 200 and 400mg. The main pharmacokinetic parameters Cmax were 1.10 ± 0.19, 2.17±0.33 and 3.16 ±0.47mg L-1, respeively;t were 7.42 ± 1.99, 8.41± 2.72 and 8.46± 2.83h, respeively; AUC were4.45± 0.71, 11.102±1.81 and 23.03 ± 3.84mg-h-L-1, respeively. The cumulative excretion rate of gatifloxacin in urine in 48h were (43.08 ±15.79)%, (51.33 + 23.69)% and (45.67 + 18.22)% of dose respeively. CONCLUSION: The plasma concentration-time curve fits two compartment model in 9 healthy volunteers after intravenous gatifloxacin mehanesulfanae in single dose (100,200 or 400mg). It suggested that the pharmacokinetics of the drug in the dosage range of 100 -400mg in human body nearly fit linear dynamic feature, and the drug mainly was excreted through kidney.