Abstract: AIM: To evaluate the tolerance of gatifloxacin mehanesulfanae after taking orlly multi-dose in Chinese healthy volunteers.METHODS: The protocol was designed according to GCP principle.After physical examination and laboratory tests, 10 volunteers (18-40yr) were invited to attend the clinical trial to evaluate the tolerance of gatifloxacin mehanesulfanae in 400 mg qd in continuous 10 days.Clinical symptoms, vital signs, routine blood tests, clotting function, routine urine tests, hepatic function, renal function, blood electrolytes, electrocardiogram, and electroencephalogram were observed or examined before and after administration.RESULTS: There was no significant clinical change in the 10 volunteers before and after administration.There was no serious ADRs during the trial, and only 2 volunteers were found the slightly increase of GPT and GOT which maybe associated with the tested drug.CONCLUSION: It is safe and tolerable that Chinese healthy volunteers were treated by gatifloxacin mehanesulfanae in 400 mg qd.in continuous 10 days.

Key words: clinical trial, gatifloxacin, tolerability, phase I trial, healthy volunteer