目的 考察中国健康受试者单次口服百可利咀嚼片后的安全性及耐受性,确定最大耐受剂量,为Ⅱ期临床试验提供给药依据。方法 随机、双盲、剂量递增、安慰剂对照I期临床试验,70例健康受试者单次口服百可利咀嚼片,通过生命体征检查、体格检查、实验室检查及不良事件等评价药物的耐受性和安全性。试验由低剂量至高剂量递增进行,研究者判断低剂量安全耐受后方可进行更高剂量组的试验。结果 100~2 800 mg百可利单次给药剂量递增试验全部完成,所有剂量组均未达到终止标准,所有受试者生命体征基本平稳,无QTc间期延长,8例受试者发生与研究药物可能有关的不良事件11例次,均为轻度,且自行缓解未予治疗,未发生严重不良事件,无受试者因不良事件而退出试验。结论 健康受试者口服创新药百可利咀嚼片100~2 800 mg安全耐受。
Abstract
OBJECTIVE To evaluate the safety and tolerability of baicalein chewable tablets and establish the maximum tolerated dose in healthy volunteers. METHODS A randomized, double-blind, dose-escalating, single-center, phase I clinical trial was conducted in 70 healthy male and female subjects. Each subject received oral baicalein only once. Adverse events were identified either by subject self-reporting or evaluation based upon vital signs, physical examination and laboratory parameters. The study was conducted from low to high dose, and the dose escalation was performed only after the safety and tolerability were confirmed favorable. RESULTS Baicalein chewable tablets were well tolerated and had an acceptable safety profile up to the highest dose of 2 800 mg. The vital signs of all subjects were stable, and no QTc interval prolongation was observed during the trial. A total of 11 mild adverse events were reported in 8 subjects. There were no severe adverse events in the study, and none of the adverse events led to withdrawal. CONCLUSION This study suggests that the innovative drug baicalein chewable tablets are well tolerated in healthy Chinese volunteers within the dose range of 100 to 2 800 mg.
关键词
百可利 /
安全性 /
耐受性 /
Ⅰ期临床试验 /
创新药
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Key words
baicalein /
safety /
tolerability /
phase Ⅰ clinical trial /
innovative drug
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中图分类号：
R969
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参考文献
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脚注
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基金
国家科技部十二五重大新药创制-心脑血管疾病新药临床评价技术平台研究课题资助项目(2012ZX09303-008-002)
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