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Bioequivalence of Oral Formulations of Anastrozole in Healthy Chinese Male Volunteers: A Randomized, Single-Dose, Two-Period, Two-Sequence Crossover Study

文献类型：期刊论文

作者Chen, Jiangying1; Zhuang, Jialang1; Wu, Jingguo2; Chen, Xiaoyan3; Wang, Xueding1; Huang, Lihui1; Zeng, Guixiong1; Chen, Jie2; Liao, Xiaoxing2; Chen, Xiao2
刊名Clinical pharmacology in drug development
出版日期2018-04-16
ISSN号2160-7648
DOI10.1002/cpdd.450
文献子类Article
英文摘要Anastrozole is currently used as first-line treatment in locally advanced or metastatic breast cancer. A generic anastrozole tablet was developed to offer an alternative to the marketed tablet formulation. The aim of the current study was to evaluate the bioequivalence between the test and reference formulations of anastrozole in a single-dose, 2-period, 2-sequence crossover study with a 14-day washout interval. A total of 20 healthy male Chinese volunteers were enrolled and completed the study, after oral administration of a single dose of 1.0-mg test and reference formulations of anastrozole. The blood samples were collected at different times and were determined by a fully validated high-pressure liquid chromatography-tandem mass spectrometry method. The evaluated pharmacokinetic parameters, including C , AUC , and AUC , were assessed for bioequivalence based on current guidelines. The observed pharmacokinetic parameters of anastrozole of the test drug were similar to those of the reference formulation. The 90% confidence intervals of test/reference ratios for C , AUC , and AUC were within the bioequivalence acceptance range of 80%-125%. The results obtained from these healthy Chinese subjects in this study suggest that the test formulation of anastrozole 1.0-mg tablet is bioequivalent to the reference formulation (Arimidex 1.0-mg tablet).
语种英语
源URL[http://119.78.100.183/handle/2S10ELR8/266326]  
专题上海药物代谢研究中心
作者单位1.Laboratory of Drug Metabolism and Pharmacokinetics, School of Pharmaceutical Sciences, Sun Yat-Sen University, Guangzhou, China;
2.The First Affiliated Hospital, Sun Yat-Sen University, Guangzhou, China;
3.Shanghai Institute of Materia Medica, Chinese Academy of Sciences, Shanghai, China
推荐引用方式
GB/T 7714		 Chen, Jiangying,Zhuang, Jialang,Wu, Jingguo,et al. Bioequivalence of Oral Formulations of Anastrozole in Healthy Chinese Male Volunteers: A Randomized, Single-Dose, Two-Period, Two-Sequence Crossover Study[J]. Clinical pharmacology in drug development,2018.
APA Chen, Jiangying.,Zhuang, Jialang.,Wu, Jingguo.,Chen, Xiaoyan.,Wang, Xueding.,...&Zhao, Xianglan.(2018).Bioequivalence of Oral Formulations of Anastrozole in Healthy Chinese Male Volunteers: A Randomized, Single-Dose, Two-Period, Two-Sequence Crossover Study.Clinical pharmacology in drug development.
MLA Chen, Jiangying,et al."Bioequivalence of Oral Formulations of Anastrozole in Healthy Chinese Male Volunteers: A Randomized, Single-Dose, Two-Period, Two-Sequence Crossover Study".Clinical pharmacology in drug development (2018).

入库方式： OAI收割

来源：上海药物研究所

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