尼麦角林片在中国健康志愿者中空腹/餐后的生物等效性试验
[Translation] A fasting/fed bioequivalence study of nicergoline tablets in Chinese healthy volunteers
主要目的:本研究以江西大生医药科技有限公司持证的尼麦角林片(规格:10mg)为受试制剂,以持证商为PFIZER ITALIA S.R.L.的尼麦角林片(商品名:SERMION,规格:10mg)为参比制剂,进行生物等效性试验。
次要目的:观察受试制剂和参比制剂在健康受试者的安全性。
[Translation] Main purpose: This study used the licensed Nicergoline Tablets (specification: 10 mg) of Jiangxi Dasheng Pharmaceutical Technology Co., Ltd. as the test preparation and the licensed Nicergoline Tablets (trade name: SERMION, specification: 10 mg) of PFIZER ITALIA S.R.L. as the reference preparation for bioequivalence test.
Secondary purpose: To observe the safety of the test preparation and the reference preparation in healthy subjects.
布立西坦片在中国健康志愿者中空腹/餐后的单次口服给药、随机、开放、两序列、两周期、交叉生物等效性试验
[Translation] A single oral fasting/fed, randomized, open-label, two-sequence, two-period, crossover bioequivalence study of brivaracetam tablets in healthy Chinese volunteers
主要研究目的,观察布立西坦片在中国健康受试者中单次口服给药后的布立西坦体内动力学过程,估算相应的药代动力学参数,并以UCB Pharma S.A.持证生产的布立西坦片 (商品名:BRIVIACT ®)为参比制剂,进行生物等效性评价。
次要研究目的,观察布立西坦片(受试制剂)和布立西坦片(商品名:BRIVIACT ®,参比制剂)在健康人体中的安全性。
[Translation] The main purpose of the study was to observe the in vivo kinetics of brivaracetam tablets after a single oral administration in healthy Chinese subjects, estimate the corresponding pharmacokinetic parameters, and use the brivaracetam tablets (trade name: BRIVIACT ®) produced by UCB Pharma S.A. as the reference preparation for bioequivalence evaluation.
The secondary purpose of the study was to observe the safety of brivaracetam tablets (test preparation) and brivaracetam tablets (trade name: BRIVIACT ®, reference preparation) in healthy humans.
100 Clinical Results associated with Jiangxi Dasheng Pharmaceutical Technology Co., Ltd
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100 Translational Medicine associated with Jiangxi Dasheng Pharmaceutical Technology Co., Ltd