| 格列喹酮片在健康人体生物等效性研究 |
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| 引用本文： | 王淑民,武峰,周辉,李嘉静,赵秀丽,王桂蓉. 格列喹酮片在健康人体生物等效性研究[J]. 中国药物应用与监测, 2011, 8(3): 139-141 |
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| 作者姓名： | 王淑民 武峰 周辉 李嘉静 赵秀丽 王桂蓉 |
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| 作者单位： | 1. 首都医科大学附属北京同仁医院药物临床试验机构,北京,100730
2. 杭州国光药业有限公司,浙江杭州,310018 |
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| 摘 要： | 目的:研究两种格列喹酮片在健康人体内的药动学特征,并评价两种制剂间的生物等效性。方法:18名健康男性志愿受试者随机交叉单剂量口服试验制剂和参比制剂60 mg,清洗期1周,采用HPLC法测定血清中格列喹酮浓度。结果:受试者口服试验制剂和参比制剂后,主要药代动力学参数如下:t1/2分别为(4.78±1.87),(4.19±1.57)h,tmax分别为(3.06±1.08),(3.28±1.49)h,Cmax分别为(0.87±0.35),(0.90±0.33)μg.mL-1,AUC0-t分别为(4.35±1.66),(4.62±1.23)μg.h.mL-1,AUC0-∞分别为(4.98±1.72),(5.19±1.42)μg.h.mL-1。试验制剂的相对生物利用度AUC0-t为(95.8±34.1)%,AUC0-∞为(97.7±29.4)%。结论:两种格列喹酮片为生物等效制剂。
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| 关 键 词： | 格列喹酮 高效液相色谱法 药代动力学 生物等效性 |
Study on bioequivalence of gliquidone tablets in healthy volunteers |
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| WANG Shu-min,WU Feng,ZHOU Hui,LI Jia-jing,ZHAO Xiu-li,WANG Gui-rong. Study on bioequivalence of gliquidone tablets in healthy volunteers[J]. , 2011, 8(3): 139-141 |
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| Authors: | WANG Shu-min WU Feng ZHOU Hui LI Jia-jing ZHAO Xiu-li WANG Gui-rong |
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| Affiliation: | WANG Shu-min1,WU Feng1,ZHOU Hui1,LI Jia-jing1,ZHAO Xiu-li1,WANG Gui-rong2(1.National Institute for Drug Clinical Trial,Beijing Tongren Hospital,Capital Medical University,Beijing 100730,China,2.Hangzhou Guoguang Pharmaceutical Co.Ltd.,Hangzhou 310018,China) |
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| Abstract: | Objective: To evaluate the pharmacokinetics and bioequivalence between two kinds of gliquidone tablets in healthy volunteers.Methods: It was designed as randomized,two-way crossover study with 1 week washout interval.Blood samples were collected after administration of a single oral dose(60 mg) of test and reference preparation in 18 healthy male volunteers.The serum concentrations of gliquidone were assayed by HPLC.Results: The pharmacokinetic parameters of test and reference preparation were as follows: t... |
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| Keywords: | Gliquidone HPLC Pharmacokinetics Bioequivalence |
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