奥扎格雷钠口服溶液Ⅰ期临床耐受性研究

Clinical tolerability of ozagrel oral liquid

目的评价健康志愿者单次口服奥扎格雷钠口服溶液的安全性并探索最大耐受剂量。方法按GCP要求设计试验方案。单剂量耐受试验将24名受试者随机分至4个剂量组,每组6名,男女各半,从低剂量开始给药,观察指标为临床症状、生命体征和实验室检查指标等,应用方差分析进行统计学处理。结果在单剂量给予奥扎格雷钠口服溶液耐受性试验中,各组受试者入选时各项指标均在正常范围,条件均衡,具有可比性。仅发现400mg剂量组有1例可能与药物有关的轻度不良反应,表现为心电图出现偶发室性期前收缩,未经处置自然消失,其他均未见有临床意义的改变。结论24名健康受试者单次口服奥扎格雷钠口服溶液,最大剂量至400mg,比较安全、耐受性好。

Objective To evaluate the safety and tolerability of single-dose of ozagrel oral liquid in Chinese healthy volunteers. Methods The protocol was designed according to the Good Clinical Practice （GCP）. Twenty-four healthy volunteers were randomly divided into 4 dosage groups（ 100mg, 200mg, 300mg and 400mg） with 3 males and 3 females in each group. Clinical symptoms, vital signs, and laboratory tests were observed before and after ozagrel administration to evaluate the adverse reactions. Results Most vital signs, clinical symptoms and laboratory tests were normal in the volunteers with single-dose ozagrel oral liquid. There was no significant clinical change. Only a case of slight and tolerable adverse drug reaction was observed. Conclusion Single-dose （as much as 400mg）ozagrel of oral liquid is safe and tolerable.