艾瑞昔布片Ⅰ期临床耐受性研究  

Phase ⅠClinical Tolerability of Imrecoxib

作　　者：黄建林[1] 潘云峰[1] 吴玉琼[1] 孙辉[2] 古洁若[1] 

机构地区：[1]中山大学附属第三医院,广州510630 [2]江苏恒瑞医药股份有限公司,江苏连云港222002

出　　处：《中国药学杂志》2011年第21期1670-1673,共4页Chinese Pharmaceutical Journal

基　　金：国家科技部863计划课题(2003AA2Z3160)

摘　　要：目的在健康成年志愿者中评价单剂量和多剂量口服艾瑞昔布片的安全性、耐受性。方法按GCP要求设计试验方案,①单剂耐受性试验拟定初试剂量为30mg,剂量递增至420 mg为最大剂量。本试验药物耐受性试验分6个剂量组,低剂量组4人,其余剂量组每组8人,安慰剂10人,共计54人,男、女各27人。将合格的健康志愿受试者随机分配至各试验组,并保证各组男、女各半。从最低剂量组开始给药,当所有单剂口服剂量组确证安全耐受后,开始多剂口服耐受性试验。②多剂耐受性试验入选12例健康男性受试者,男女各半,给药方法:200 mg bid,餐后30 min服药连服11 d。观察指标为临床症状、体征和实验室检查指标等。结果研究中未发现药物对生命体征有不良影响。试验中发现胆红素升高7例(其中安慰剂组1例),不良事件与研究药物可能有关,程度轻。其他不良事件(包括恶心、上腹痛、肠鸣音活跃、脐周腹痛、解烂便、腹泻、腹痛、大便潜血阳性等)研究者认为与药物可能无关。结论单次给药(30～420 mg)及连续给药(200 mg,bid)11 d在健康志愿者中的耐受性好,有关胆红素升高及大便潜血阳性的不良事件与药物的关系,建议在Ⅱ期临床试验中进一步观察。OBJECTIVE To evaluate the safety and tolerability of single-dose and multi-dose oral of imrecoxib in Chinese healthy volunteers. METHODS The protocol was designed according to the Good Clinical Practice（GCP） . 54 healthy volunteers of 19 - 35 years old were randomly divided into 6 dosage groups from 30 mg to 420 mg with 2 - 4 males and 2 - 4 females in each group, 6 males and 6 females volunteers were administered imrecoxib 200mg twice a day for 11 days . Clinical symptoms , vital signs and laboratory tests were recorded before and after oral of imrecoxib to evaluate the adverse reactions. RESULTS After single dose oral of imrecoxib, vital signs and clinical symptoms were normal. There were no significant clinical changes or severe advert reactions （ADRs）. 7 cases of slight elevation of bilirubin as ADRs which were probably related to the drug were observed. CONCLUSION Single dose up to the maximum dose of 420 mg and multi-dose of oral imrecoxib were safe and tolerable.

关 键 词：艾瑞昔布 Ⅰ期临床 耐受性研究 

分 类 号：R969[医药卫生—药理学]