替硝唑片在中国健康受试者中的生物等效性研究  

Bioequivalence of tinidazole tablets in healthy Chinese volunteers

作　　者：王敏 王丽珍 朱珍真 张丽 郎丽巍 刘佳琦 于宏坡 武艺伟 李瑶 胡海棠[4] 邓德城 岳金涛 魏振满 WANG Min;WANG Li-zhen;ZHU Zhen-zhen;ZHANG Li;LANG Li-wei;LIU Jia-qi;YU Hong-po;WU Yi-wei;LI Yao;HU Hai-tang;DENG De-cheng;YUE Jin-tao;WEI Zhen-man(Drug Trial Center,Fifth Medical Center of Chinese People’s Liberation Army General Hospital,Beijing 100039,China;Department of Pharmacy,Medical Security Center Stationed in the 5th Medical Center Pharmacy Room,People’s Liberation Army General Hospital,Beijing 100039,China;Beijing Garrison Haidian 17th Retired Cadres Recuperation,Beijing 100036,China;Livzon(Group)Pharmaceutical Factory,Zhuhai 519090,Guangdong Province,China;Beijing Haijinge Pharmaceutical Technology Co.LTD,Beijing 100071,China)

机构地区：[1]中国人民解放军总医院第五医学中心药物试验中心,北京100039 [2]解放军总医院医疗保障中心,药剂科,派驻第五医学中心,药剂室,北京100039 [3]北京卫戍区海淀第十七退休干部休养所,北京100036 [4]丽珠集团丽珠制药厂,广东珠海519090 [5]北京海金格医药科技股份有限公司,北京100071

出　　处：《中国临床药理学杂志》2020年第22期3577-3580,共4页The Chinese Journal of Clinical Pharmacology

摘　　要：目的评价2种替硝唑片在中国健康受试者中的生物等效性及安全性。方法按单中心、随机、开放、单次给药、两序列、两制剂、两周期、交叉试验研究设计方法,在餐后条件下,共入组24例健康受试者,随机交叉单次口服受试制剂和参比制剂各500 mg,用HPLC-MS/MS法来测定受试者血浆中替硝唑浓度,用Phoenix WinNonlin(7.0版本)软件以计算替硝唑药代动力学参数,并进行生物等效性评价。结果受试者在服用受试制剂和参比制剂后,其血浆中替硝唑主要药代动力学参数如下:Cmax分别为(1.21×10^4±2048.85)和(1.20×10^4±2132.68) ng·mL^-1;AUC0-t分别为(24.93×10^4±3.62×10^4)和(24.55×10^4±3.06×10^4) ng·h·mL^-1;AUC0-∞分别为(25.96×10^4±3.91×10^4)和(25.60×10^4±3.27×10^4) ng·h·mL^-1。2种制剂的Cmax、AUC0-t和AUC0-∞经对数转换后的90%可信区间为96.11%~106.45%,99.41%~103.12%,99.25%~103.02%。结论 2种替硝唑片在中国健康受试者中具有生物等效性。Objective To evaluate the bioequivalence of two kinds of tinidazole tablets in China healthy subjects. Methods This was a single-center, randomized, open-label, single-dose, two-period, cross-over pharmacokinetic study. A total of 24 subjects in a fed state were given single oral dose of test and reference preparation of tinidazole tablets(each 500 mg), respectively. The concentration of tinidazole in human plasma was measured by HPLC-MS/MS. Main pharmacokinetic parameters were calculated by using Phoenix WinNonlin(V7.0) software. Results The main pharmacokinetic parameters of tinidazole of the test and reference preparations were as follows: the fed state Cmax were(1.21×10^4±2048.85) and(1.20×10^4±2132.68) ng·mL^-1;AUC0-t were(24.93×10^4±3.62×10^4) and(24.55×10^4±3.06×10^4) ng·h·mL^-1;AUC0-∞ were(25.96×10^4±3.91×10^4) and(25.60×10^4±3.27×10^4) ng·h·mL^-1. The 90% confidential interval of Cmax, AUC0-t and AUC0-∞ of tested formulation in the fed state were 96.11%-106.45%, 99.41%-103.12%,99.25%-103.02%. Conclusion Two kinds of tinidazole tablets are determined to be bioequivalent.

关 键 词：替硝唑 药代动力学 血药浓度 生物等效性 

分 类 号：R97[医药卫生—药品]