单剂量口服琥珀八氢氨吖啶片在健康人体的耐受性

Tolerance of octohydroaminoacridine succinate tablets after single dose administration in Chinese healthy volunteers

目的评价健康受试者单剂量口服不同剂量琥珀八氢氨吖啶片(改善老年性记忆功能障碍药)的安全性和耐受性。方法采用随机、开放、剂量递增的单中心研究,28名符合要求的受试者,分别单剂量口服琥珀八氢氨吖啶片1,2,4,6,8和12mg。用药后,定时对受试者进行临床观察、心电图检查和实验室检查。结果 28名受试者全部完成研究。出现1例与研究药物有关的不良事件,在随访期,出现血尿素升高,7d后自愈。结论单剂量口服琥珀八氢氨吖啶片1～12mg对于健康受试者是安全的,耐受性良好。

Objective To evaluate the safety and tolerance of single dose octohydroaminoacridine succinate tablets in Chinese healthy volunteers.Methods A randomized,open-label,dose-escalation and single center clinical trial was conducted in 28 eligible volunteers.Each subject received a single oral dose of 1,2,4,6,8 and 12 mg of octohydroaminoacridine succinate tablets in randomized way.After single-dose drug delivery,vital signs,ECG and laboratory parameters were observed.Results All 28 subjects completed the study.No subjects present any adverse event except one whose urea increased at follow-up after dosing,and self-cure 7 days later.Conclusion Octohydroaminoacridine succinate tablets is safe and tolerance in Chinese healthy subjects who participated in the study,and the dose range is 1-12 mg for single-dose administration.