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目的 在中国健康成年男性志愿者中 ,评估单次口服新型催醒药莫达芬尼片的安全性、耐受性。方法 选择 30名 18岁～ 5 0岁健康成人 ,用区组随机化设计方法 ,将受试者随机分配至 5 0、10 0、2 0 0、30 0、4 0 0mg组 ,每组 6名受试者。观察指标为临床症状体征 ,实验室指标包括心电图、脑电图、血常规、尿常规、肝功能、肾功能、电解质等。严密观察并记录试验期间发生的不良反应事件。同时 ,观察药物对受试者睡眠的影响。结果 各组入选受试者各项指标测定值均在正常范围 ,条件均衡 ,具较好可比性。给药后体温、呼吸频率、脉搏、血压、实验室检查肾功能、电解质等未见有临床意义的改变。各剂量组受试者在给药后 ,均发现有不同程度的睡眠减少现象。试验中 ,未见严重的临床不良反应 ,仅发现三例轻度一过性不良反应 ,其中 2 0 0mg组一例 ,表现为GPT升高 ,4 0 0mg组二例 ,表现为体温升高。结论 30名健康受试者分组单次口服莫达芬尼片 ,最大剂量至4 0 0mg,比较安全、耐受性较好。
Objective To evaluate the safety and tolerability of a single oral administration of a new drug, modaparin, in healthy adult male volunteers in China. Methods Thirty healthy adults, aged 18 to 50 years old, were randomly divided into 5 groups, 10 0,2 0 0,30 0,4 0 0 mg group by randomized block design method, 6 in each group Subjects. Observed indicators of clinical signs, laboratory indicators including ECG, EEG, blood, urine, liver function, renal function, electrolytes and so on. Closely observe and record the adverse events occurred during the trial. At the same time, observe the effect of the drug on the subject’s sleep. Results All subjects were selected subjects were measured in the normal range, the conditions are balanced, with better comparability. There were no clinically significant changes in body temperature, respiratory rate, pulse rate, blood pressure, laboratory tests of renal function, electrolytes, etc. after administration. Subjects in each dose group were found to have varying degrees of decreased sleep after administration. No severe clinical adverse reactions were observed in the trial, and only three mild transient adverse reactions were found. One of the 200 mg patients showed an increase in GPT, and two patients in the 400 mg group showed elevated body temperature. Conclusion A total of 30 healthy subjects were given a single oral dose of modafinil tablets at a maximum dose of 400 mg, which was safe and well tolerated.