尼麦角林片在健康受试者中的随机、开放、单剂量、自身交叉空腹及餐后生物等效性试验
[Translation] A randomized, open-label, single-dose, self-crossover bioequivalence study of nicergoline tablets in healthy subjects under fasting and fed conditions
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] Primary objective: To compare the relative bioavailability of Nicergoline Tablets (specification: 10 mg) produced by Beijing Jiuneng Tianyuan Technology Co., Ltd. with Nicergoline Tablets (specification: 10 mg, trade name: Sermion®, reference preparation) certified by Pfizer Italia S.r.l./Upjohn EESV in healthy human bodies, and investigate the bioequivalence of the two preparations.
Secondary objective: To observe the safety of Nicergoline Tablets test preparation and reference preparation (trade name: Sermion®) in healthy subjects.
100 Clinical Results associated with Beijing Jiuneng Tianyuan Technology Co., Ltd.
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100 Translational Medicine associated with Beijing Jiuneng Tianyuan Technology Co., Ltd.