[Translation] Randomized, open-label, single-dose, self-crossover fasting and postprandial bioequivalence trials of nicergoline tablets in healthy subjects
主要目的:以北京九能天远科技有限公司生产的尼麦角林片(规格:10 mg)为受试制剂,按生物等效性试验的有关规定,与Pfizer Italia S.r.l./Upjohn EESV持证的尼麦角林片(规格:10 mg,商品名:Sermion®,参比制剂)对比在健康人体内的相对生物利用度,考察两制剂的人体生物等效性。
次要目的:观察尼麦角林片受试制剂和参比制剂(商品名:Sermion®)在健康受试者中的安全性。
[Translation] Main purpose: Taking Nicergoline Tablets (specification: 10 mg) produced by Beijing Jiuneng Tianyuan Technology Co., Ltd. Ergoline tablets (specification: 10 mg, trade name: Sermion®, reference preparation) were compared with the relative bioavailability in healthy humans, and the human bioequivalence of the two preparations was investigated.
Secondary purpose: To observe the safety of Nicergoline tablets test preparation and reference preparation (trade name: Sermion®) in healthy subjects.