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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。
Objective To evaluate the safety and tolerability of a single oral dose of soxhloxacin hydrochloride in healthy volunteers. Methods 72 subjects were randomized into seven incremental doses of 50 mg dose group of 8 (test preparation and placebo ratio of 3: 1), were given 50 mg of loxoxarsine hydrochloride; 100,200,300 mg dose group of 10 ( Test preparation and placebo ratio of 4: 1), were given 100, 200, 300 mg of loxoxacin hydrochloride; 400 and 600 mg dose group of 12 (test preparation and placebo ratio of 2: 1), respectively, mg; 800 mg dose group of 10 (test preparation and placebo ratio of 3: 2), to be given oxysalicylate 800 mg. Subjects were observed after treatment of vital signs, regular laboratory tests, ECG and EEG traces. RESULTS: All 72 subjects completed the study. One patient in the 400 mg dose group had bruising of the left ankle on day 3 and increased creatine kinase, not in the study drug; one dose of 600 mg Mild dizziness, 800 mg dose group 2 subjects mild nausea, and research drugs may be related. Other subjects had no adverse events. CONCLUSION: Sooxifloxacin hydrochloride is well tolerated in a single oral dose of 50-800 mg.