盐酸索西沙星片在健康人体单次给药的耐受性

发布时间：2018-06-12 13:51

本文选题：盐酸索西沙星 + 单次口服　；参考：《中国临床药理学杂志》2015年16期

【摘要】：目的评价健康受试者单次口服不同剂量盐酸索西沙星的安全性和耐受性。方法 72名受试者随机进入7个递增剂量组,50 mg剂量组8人(受试制剂与安慰剂比为3∶1),予以盐酸索西沙星50 mg;100,200,300 mg剂量组各10人(受试制剂与安慰剂比为4∶1),分别予以盐酸索西沙星100,200,300 mg;400,600 mg剂量组各12人(受试制剂与安慰剂比为2∶1),分别予以盐酸索西沙星400,600 mg;800 mg剂量组10人(受试制剂与安慰剂比为3∶2),予以盐酸索西沙星800 mg。用药后观察受试者的生命体征,定时进行实验室检查、心电图和脑电图描记。结果 72名受试者全部完成了研究,400 mg剂量组1例受试者在服药第3天左踝部碰伤,伴肌酸激酶升高,与研究药物无关;600 mg剂量组出现1例轻度头晕,800 mg剂量组2例受试者出现轻度恶心,与研究药物可能有关。其他受试者无不良事件。结论在50~800 mg剂量范围内单次口服盐酸索西沙星耐受性良好。
[Abstract]:Objective to evaluate the safety and tolerance of a single oral dose of Sosifloxacin hydrochloride in healthy volunteers. Methods Seventy-two subjects were randomly assigned to 7 incremental dose groups with a dose of 50 mg (the ratio of the test preparation to the placebo was 3: 1), and 10 subjects were given Sosifloxacin hydrochloride 50 mg / L 100200300 mg / mg group (the ratio of the test preparation to the placebo was 4: 1). 12 patients in each group were given Soxifloxacin hydrochloride 100200300 mg / kg 400600mg group (the ratio of test preparation to placebo was 2: 1), and 10 patients were given Sosifloxacin hydrochloride 400600 mg / L 800mg / mg group (the ratio of test preparation to placebo was 3: 2) and the dose of Sosifloxacin hydrochloride was 800mg / g. After medication, the vital signs of the subjects were observed, laboratory examination, electrocardiogram and electroencephalography were performed regularly. Results all 72 subjects completed the study. One patient in the 400mg group was injured in the left malleolus on the 3rd day, accompanied by the increase of creatine kinase. There was 1 case of mild dizziness in the 600mg group and 2 subjects in the 800mg group had mild nausea, which might be related to the drug study. Other subjects had no adverse events. Conclusion Susifloxacin hydrochloride has good tolerance in the dose range of 50 mg / 800 mg.
【作者单位】：北京大学第一医院临床药理研究所;浙江医药股份有限公司新昌制药厂;
【分类号】：R969.1

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