盐酸戊乙奎醚片单次给药人体耐受性研究

发布时间：2018-03-16 22:02

本文选题：盐酸戊乙奎醚　切入点：I期临床试验　出处：《中国新药杂志》2015年07期 　论文类型：期刊论文

【摘要】：目的:初步评价健康人体对盐酸戊乙奎醚片单次给药剂量的耐受性,为多次给药及II期临床试验推荐安全剂量。方法:单次给药试验中36例受试者随机分为8个剂量组,分别给予盐酸戊乙奎醚片0.1,0.2,0.3,0.4,0.6,0.8,1.0,1.2 mg。每位受试者只接受1个相应剂量,观察受试者的临床症状、生命体征、实验室检查、心电图检查及不良事件等。结果:实际完成试验方案32例。给药后受试者心率显著减慢(P0.05),但无剂量依赖性。1.0 mg剂量组视近物模糊的发生率超过50%。心电图检查发现窦性心动过缓和窦性心律不齐情况,个别受试者有I°房室传导阻滞和频发房性早搏等不良事件发生。实验室检查未见有临床意义的异常。结论:盐酸戊乙奎醚片在健康受试者单次给药时安全性和耐受性良好,最大耐受剂量为0.8 mg,推荐多次给药第一组剂量为0.6 mg·d-1。
[Abstract]:Objective: to evaluate the tolerance of healthy volunteers to single dose of penehyclidine hydrochloride tablets, and to recommend a safe dose for multiple administration and phase II clinical trials. Methods: 36 subjects were randomly divided into 8 dose groups. Penehyclidine hydrochloride tablets were given 0.1U 0.2g 0.3ng 0.4U 0.6U 0.81.0U 1.2mg. each subject received only one corresponding dose to observe the clinical symptoms, vital signs and laboratory tests of the subjects, and to observe the clinical symptoms, vital signs and laboratory tests of the subjects. Results: 32 cases of trial scheme were completed. After administration of the drug, the heart rate of the subjects slowed down significantly (P 0.05), but the incidence of visual blur in the dose independent group of 1.0 mg was more than 50%. Electrocardiogram (ECG) showed that the heart rate of the patients was significantly lower than that of the control group (P < 0.05). Sinus tachycardia, sinus arrhythmia, Adverse events such as I 掳atrioventricular block and frequent atrial premature beats occurred in individual subjects. Laboratory tests showed no significant abnormalities. Conclusion: pentanethaquine hydrochloride tablets are safe and well tolerated in healthy volunteers. The maximum tolerated dose was 0.8 mg / g, and the recommended dose of the first group was 0.6 mg 路d ~ (-1).
【作者单位】：成都军区总医院临床药学科;
【分类号】：R969

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