枸橼酸西地那非片生物等效性试验研究现状及其审评要求  

Progress and review requirement for Sildenafil Citrate Tablet bioequivalence test

作　　者：刘冬 韩鸿璨 王骏 LIU Dong;HAN Hongcan;WANG Jun(Center for Drug Evaluation,National Medical Products Administration,Beijing 100022,China)

机构地区：[1]国家药品监督管理局药品审评中心,北京100022

出　　处：《药物评价研究》2023年第3期677-682,共6页Drug Evaluation Research

摘　　要：枸橼酸西地那非片主要用于治疗男性勃起功能障碍,并适用于治疗成人肺动脉高压,属临床常用药物。结合美国、中国该品种生物等效性试验指导原则要求,通过对近年来中国开展的枸橼酸西地那非片生物等效性试验结果进行总结、分析,并对生物等效性试验审评中发现的多种情况提出一般考虑。枸橼酸西地那非片一般选择40例男性健康受试者开展空腹及餐后生物等效性试验,口崩片则建议仅开展空腹生物等效性试验;建议关注生物等效性试验中受试制剂与参比制剂达峰时间(t_(max))的非参数检验结果。Sildenafil Citrate Tablet is used for the treatment of male erectile dysfunction and pulmonary arterial hypertension,which is a common drug in clinic.Combining with the United States and China bioequivalence test guidelines requires,summary and analysis based on recent years bioequivalence result of Sildenafil Citrate Tablet in China,and propose general consideration on bioequivalence results of review.For Sildenafil Citrate Tablet bioequivalence research and development provide scientific basis and reference.About 40 healthy male subjects of Sildenafil Citrate Tablets were selected for fasting and fed bioequivalence tests,while only fasting bioequivalence was recommended for orally disintegrating tablets.At the same time,it was recommended to pay attention to the non-parametric test results of t_(max)between the test and reference in the bioequivalence test.

关 键 词：枸橼酸西地那非片 仿制药 生物等效性试验 审评要求 非参数检验 

分 类 号：R951[医药卫生—药学]