中国健康受试者单次口服格列美脲耐受性试验

Investigation on the Tolerance of Domestic Glimepiride with a Single Oral Dose hi Chinese Healthy Volunteers

采用随机试验研究40名中国健康志愿者单次口服国产格列美脲的耐受性。结果表明:单次口服1～10mg格列美脲,受试者体温、脉搏、血压、心电图、脑电图、血常规、尿常规、血沉、肝功能、肾功能、电解质等各项指标测定值均在正常范围内,仅见少数血糖降低(8例次)、头晕(2例次)等一过性轻微的不良反应。提示:国人对单次口服格列美脲至10mg剂量比较安全,耐受性较好。

A randomized phase I of clinical trial was performed to study the safety and tolerance of single oral dose domestic glimepiride in 40 Chinese healthy volunteers. It was shown that after single oral doses of 1 - 10mg , the vital signs,the clinical symptoms and the laboratory tests were in the normal range, eg. body temperature, pulse rate, blood pressure, EGG, EEG, blood routine, urine routine, ESR, hepatic function, renal function, and electrolyte. However, we found some slight ADRs, such as hypoglycemia and dizziness after administration. It suggests that the single dose up to lOmg of domestic glimepiride in chinese healthy volunteers was safe and tolerable.