谱圣康口服液Ⅰ期临床人体耐受性试验研究  

PhaseⅠclinical tolerance study of Picika oral solution in healthy volunteers

作　　者：段锋[1] 毕京峰[1] 陈本超[1] 朱珍真[1] 孙斌[1] 陈贞[1] 张宇[1] 储艳艳 张丽[1] 王敏[1] 李文淑[1] 金城[1] 魏振满[1] 

机构地区：[1]解放军第302医院新药临床试验中心,北京100039

出　　处：《中国临床药理学杂志》2014年第10期912-914,共3页The Chinese Journal of Clinical Pharmacology

基　　金：“十二五”国家重大新药创制基金资助项目(2012ZX09303013)

摘　　要：目的评价谱圣康口服液单次及多次给药在健康人体内的耐受性和安全性。方法单中心、随机、单盲、安慰剂对照、剂量递增的试验设计。60例受试者,其中单次给药50例,多次给药10例,男女各半。单次给药:20 mL组4名,40mL组6名,60 mL组10名(安慰剂2名),90 mL组10名(安慰剂2名),120 mL组10名(安慰剂2名),160 mL组10名(安慰剂2名);多次给药组,10名(安慰剂2名),每次40 mL,tid,连续用药10 d。结果 60例健康受试者入选,实际完成58例,2例脱落。单次给药160 mL组1例女性活化部分凝血酶原时间(APTT)异常,判断异常有临床意义,与用药可能无关;多次给药报告1例女性腹痛,与用药可能无关。结论健康受试者单次或多次给予谱圣康均安全且有较好的耐受性。Objective To study the tolerability and safety of single and multiple doses of Picika oral solution in healthy volunteers. Methods A single center, randomized, single - blind, placebo - controlled, dose - escalation study was designed. 50 patients were given single dose, and 10 cases were given multiple doses. All of them had half male and fe- male. Single- dose group： 20 mL（4 subjects）, 40 mL（6 subjects） , 60 mL（10 subjects; 2 using placebo）, 90 mL（10 subjects; 2 using place- bo）, 120 mL （10 subjects ; 2 using placebo）, 160 mL （10 subjects; 2 using placebo） ; multiple doses group： 10 subjects（2 using placebo）, 40 mL ·times^-1 , tid, continuous medication for 10 days. Results Of the sixty healthy subjects enrolled, 58 finally completed the trial, and two shed. One case （female） of adverse event in single -dose 160 mL group was reported： her ctivated partial thromboplastin time （APTY） was abnormal with clinical significance. It may not be associated with the medication. In multiple doses group, one case of abdominal pain （female） was reported, may not be associated with the medication. Conclusion Single and multiple doses of Picika oral solution are safe and well tolerated in healthy subjects.

关 键 词：谱圣康口服液 Ⅰ期临床试验 耐受性 

分 类 号：R969.4[医药卫生—药理学] R979.5[医药卫生—药学]