单次口服格列美脲片的Ⅰ期临床耐受性研究

Phase Ⅰ clinical trial on tolerability of glimepiride in single oral dose

目的 :评价健康志愿者单次口服格列美脲片的安全性和耐受性。方法 :选择 18～ 5 0岁健康男性 ,按随机表将 36例受试者随机分配至 1,2 ,4,6 ,8和 10mg 6个剂量组 ,观察指标为临床症状、生命体征、血常规、血沉、尿常规、肝肾功能、电解质等实验室检查 ,并测心电图、脑电图。结果 :早、中、晚餐后 2h血糖和次晨 3点血糖明显降低。不良反应发生率约为 2 8% (10 /36 ) ,最常见的不良反应为低血糖反应。结论 :36例健康受试者单次口服格列美脲片最大剂量至 10mg比较安全 ,耐受性较好。

Objective:To evaluate the safety and tolerability of glimepiride in 36 Chinese healthy volunteers.Methods:The 36 male volunteers of 18～50 years old were selected in accordance with the parameters of physical examination and laboratory test.The volunteers were equally divided to receive 1,2,4,6,8,and 10 mg of single oral dose of glimepiride and the specified parameters were observed.Results:The blood glucose level 2h after breakfast,lunch and supper,as well as 3 AM next morning were significantly reduced with a total side effective rate of 28%(10/36).The most common side effect was hypoglycemia.Conclusion:The glimepiride is safe and tolerable at the maximum tested dose of 10 mg with mild and transient side effects.