中国健康女性受试者单次及多次口服马来酸甲麦角新碱片剂的安全性和耐受性研究  

Tolerability to single oral dose and multiple oral doses of methylergometrine maleate tablets in Chinese healthy female volunteers

作　　者：董凡[1] 薛薇[1] 李扬[1] 李敏[1] 严蓓[1] 史爱欣[1] 胡欣[1] 

机构地区：[1]北京医院临床试验研究中心,药物临床风险与个体化应用评价北京市重点实验室,北京100730

出　　处：《中国新药杂志》2018年第5期549-553,共5页Chinese Journal of New Drugs

基　　金：国家“重大新药创制”科技重大专项资助项目(2012ZX09303-008-002)

摘　　要：目的:考察中国健康女性受试者单次及多次口服马来酸甲麦角新碱片的安全性及耐受性。方法:随机、开放Ⅰ期临床试验,36例健康女性受试者随机进入0.125,0.25和0.5 mg组。其中,0.25 mg与0.5 mg组进行单次给药试验,0.125 mg组在完成单次给药试验后继续进行多次给药试验。通过生命体征检查、体格检查、实验室检查及不良事件(AE)等评价受试者对试验药物的耐受性和安全性。结果:36例受试者全部完成试验,所有剂量组试验均未达到终止标准。共6例受试者发生与试验药物可能有关的AE 9例次,单次给药试验0.125 mg组及0.25 mg组未发生AE,0.5 mg组4例受试者共发生AE 7例次,0.125 mg组多次给药试验中2例受试者发生AE 2例次。本试验发生的AE均为轻度,均自行好转或痊愈,未发生严重不良事件(SAE)。结论:中国健康女性受试者单次口服0.125~0.5 mg和多次口服0.125 mg马来酸甲麦角新碱片安全耐受。Objective： To evaluate the safety and tolerability of single dose and multiple doses of methylergometrine maleate tablets in healthy female volunteers. Methods： A randomized,open,phase I clinical trial was conducted in 36 healthy female subjects. Thirty-six subjects were randomly assigned to 3 cohorts and received methylergometrine at doses ranging from 0. 125 mg to 0. 5 mg. The doses of 0. 25 and 0. 5 mg were administered only in single dose trial,while the other cohorts received multiple doses of 0. 125 mg. Adverse events（AEs） were identified either by subject self-reporting or based upon vital signs,physical examination and laboratory parameters.Results： All the subjects completed the trial. A total of 9 AEs were reported in 6 subjects. There were no severe adverse events in the study,and none of the AEs led to withdrawal. Among the AEs,no AE was reported in 0. 125 mg and 0. 25 mg single dose trials,but 7 AEs in 4 subjects were reported in single dose group of 0. 5 mg. In multiple dose trial,2 AEs in 2 subjects were reported in the cohort of 0. 125 mg. Conclusion： Methylergometrine maleatetablet is well tolerated in healthy female Chinese volunteers within the dose range of 0. 125 mg to 0. 5 mg.

关 键 词：甲麦角新碱 中国健康女性受试者 安全性 耐受性 Ⅰ期临床试验 

分 类 号：R969[医药卫生—药理学]