受试制剂和参比制剂 Test Product and Reference Product T and
Conclusion:Test product: nifedipine sustained release tablet (manufac- ture in Tianjing Taipingyang pharmaceutical limited company, specification: 10mg/tablet;batch numbe- r:070101) and reference product: nifedipine sustained release tablet(made in Yangzijiang limited company,trade name Huy- ou,specification:10mg/tablet,batch number:07051001) are bio- equivalent in healthy volunteers.
结论:综合单次给药和多次给药实验结果,可以判定受试制剂硝苯地平缓释片(天津太平洋制药有限公司研制,规格:10mg/片,批号:070101),与参比制剂硝苯地平缓释片(扬子江药业集团江苏制药股份有限公司生产,商品名:护佑,规格:10mg/片;批号:07051001),在健康志愿受试者体内具有生物等效性。
参考来源 - 硝苯地平缓释片在健康志愿受试者体内的生物利用度和生物等效性研究·2,447,543篇论文数据，部分数据来源于NoteExpress
目的：评价受试制剂盐酸左氧氟沙星片和胶囊与参比片剂人体生物等效性。
Objective:To evaluate the bioequivalence of levofloxacin tablet or capsule and reference tablet in healthy volunteers.
方法采用随机二交叉设计试验，20例男性健康志愿受试者，单剂量口服受试制剂盐酸金刚乙胺颗粒和参比制剂盐酸金刚乙胺片。
METHODS A single oral dose of two preparations was given to 20 healthy male volunteers according to a randomized crossover design.
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