[Translation] A randomized, open-label, single-dose, double-cycle, self-crossover fasting and postprandial bioequivalence trial of mirtazapine tablets in healthy subjects
以华裕(无锡)制药有限公司生产的米氮平片(商品名:派迪生®,30mg/片)为受试制剂,以N.V.Organon生产,杭州默沙东制药有限公司分装的米氮平片(商品名:瑞美隆®,30mg/片)为参比制剂,按生物等效性试验的相关规定,比较米氮平片在中国健康受试者体内的药代动力学行为,评价两种制剂的生物等效性。
[Translation] Take mirtazapine tablets (trade name: Pedisson®, 30mg/tablet) produced by Huayu (Wuxi) Pharmaceutical Co., Ltd. as the test preparation, and produced by N.V. Organon and subpackaged by Hangzhou Merck & Co., Ltd. ( Trade name: Remelon®, 30mg/tablet) is the reference preparation. According to the relevant regulations of the bioequivalence test, the pharmacokinetic behavior of mirtazapine tablets in Chinese healthy subjects was compared, and the two preparations were evaluated. bioequivalence.