CAJ | 학술논문

谱圣康口服液I期临床人体耐受性试验研究
보골강구복액I기림상인체내수성시험연구
PhaseⅠclinical tolerance study of Picika oral solution in healthy volunteers

万方数据

中国临床药理学杂志中國臨床藥理學雜誌 중국림상약이학잡지
THE CHINESE JOURNAL OF CLINICAL PHARMACOLOGY
2014年 10期 912-914 ,共3页

段锋%毕京峰%陈本超%朱珍真%孙斌%陈贞%张宇%储艳艳%张丽%王敏%李文淑%金城%魏振满

단봉%필경봉%진본초%주진진%손빈%진정%장우%저염염%장려%왕민%리문숙%금성%위진만

谱圣康口服液%Ⅰ期临床试验%耐受性譜聖康口服液%Ⅰ期臨床試驗%耐受性
보골강구복액%Ⅰ기림상시험%내수성
Picika oral solution%phase Ⅰ clinical%tolerance

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，40 mL 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。
목적：평개보골강구복액단차급다차급약재건강인체내적내수성화안전성。방법단중심、수궤、단맹、안위제대조、제량체증적시험설계。60례수시자，기중단차급약50례，다차급약10례，남녀각반。단차급약：20 mL 조4명，40 mL 조6명，60 mL 조10명（안위제2명），90 mL 조10명（안위제2명），120 mL조10명（안위제2명），160 mL 조10명（안위제2명）；다차급약조，10명（안위제2명），매차40 mL，tid，련속용약10 d。결과60례건강수시자입선，실제완성58례，2례탈락。단차급약160 mL 조1례녀성활화부분응혈매원시간（APTT）이상，판단이상유림상의의，여용약가능무관；다차급약보고1례녀성복통，여용약가능무관。결론건강수시자단차혹다차급여보골강균안전차유교호적내수성。
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 (APTT) was ab-normal with clinical significance.It may not be associated with the medi-cation.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 tolera -ted in healthy subjects.