关键词: 注射用磷酸左奥硝唑酯二钠, 多次静脉滴注, 耐受性试验

Abstract: Objective To assess the safety and tolerability of levornidazole disodium phosphate for injection in Chinese healthy volunteers. Methods 24 healthy subjects were enrolled in the multi-dose trial (male:female=1:1). Subjects were equally divided into two groups, received intravenous infusion of 1 000 mg twice daily and 2 000 mg once daily for consecutive 7 days. The safety and tolerability were evaluated based on clinical symptoms, vital signs, physical examinations, ECG, laboratory tests and adverse events. Results Levornidazole disodium phosphate had no clinically significant effects on vital signs and ECG in total of 24 subjects who completed the tolerance test. 19 adverse events were observed in 12 subjects, including ALT elevation, AST elevation, LDH elevation and pain at the injection site, which were somewhat related to the study drug judged by investigator. But they were slight and temporary and completely relieved without any intervention. There was no serious adverse event or any adverse event leading to drop-out. Conclusion Levornidazole disodium phosphate for injection is well-tolerated in Chinese healthy subjects after administration of multi-doses (1 000 mg twice daily and 2 000 mg once daily). The main adverse reactions were ALT and AST mild increase, which were also consistent with previous reports that hepatic metabolism is the main elimination for ornidazole. In the multi-dose trial, safty and tderability of 2 000 mg once daily is bettert than that of the other.

Key words: levornidazole disodium phosphate for injection, multi-dose intravenous injection, tolerance trial