/ CompletedNot Applicable 一项随机、开放、两序列交叉设计,评价健康成人空腹/餐后状态下单次口服磷酸特地唑胺片的生物等效性试验
[Translation] A randomized, open-label, two-sequence crossover design study to evaluate the bioequivalence of a single oral dose of tedizolid phosphate tablets in healthy adults under fasting/fed conditions
主要目的:考察中国健康受试者在空腹/餐后条件下单剂量口服浙江东亚药业股份有限公司生产的磷酸特地唑胺片(规格:200mg)与持证商为 MSD Pharma(Singapore) Pte Ltd生产厂家为Patheon Inc.的磷酸特地唑胺片(商品名:SIVEXTRO®;规格:200mg)后的体内药代动力学特征,评价两制剂的生物等效性。
次要目的:评价单剂量口服磷酸特地唑胺片受试制剂(规格:200mg)及参比制剂(商品名:SIVEXTRO®;规格:200mg)在中国健康受试者中的安全性。
[Translation] Primary objective: To investigate the in vivo pharmacokinetic characteristics of Tedizolid Phosphate Tablets (Specification: 200 mg) produced by Zhejiang East Asia Pharmaceutical Co., Ltd. and Tedizolid Phosphate Tablets (trade name: SIVEXTRO®; specification: 200 mg) produced by MSD Pharma (Singapore) Pte Ltd and manufactured by Patheon Inc. after a single oral dose in healthy Chinese subjects under fasting/postprandial conditions, and to evaluate the bioequivalence of the two preparations.
Secondary objective: To evaluate the safety of the test preparation (specification: 200 mg) and reference preparation (trade name: SIVEXTRO®; specification: 200 mg) of Tedizolid Phosphate Tablets in healthy Chinese subjects after a single oral dose.
/ CompletedNot Applicable 随机、开放、交叉对照设计,评价中国健康受试者在空腹状态下单次口服依帕司他片后的生物等效性正式试验
[Translation] A randomized, open-label, crossover controlled study to evaluate the bioequivalence of epalrestat tablets in healthy Chinese subjects after a single oral dose in the fasting state
主要目的:以浙江东亚药业股份有限公司提供的依帕司他片为受试制剂,按生物等效性试验的有关规定,与アルフレッサファーマ株式会社持证的依帕司他片(商品名:KINEDAK®,参比制剂)对比在健康人体内的吸收速度及吸收程度,考察两制剂的人体生物等效性。
[Translation] Main objective: To use epalrestat tablets provided by Zhejiang East Asia Pharmaceutical Co., Ltd. as the test preparation and compare their absorption rate and extent in healthy humans with those of epalrestat tablets (trade name: KINEDAK®, reference preparation) certified by Alpharestat Pharmaceuticals Co., Ltd. according to the relevant provisions of bioequivalence studies, and to investigate the bioequivalence of the two preparations in humans.
/ Active, not recruitingNot Applicable 富马酸伏诺拉生片(20mg)在中国健康受试者中空腹和餐后给药条件下随机、开放、单剂量、两序列、两周期、双交叉生物等效性试验
[Translation] A randomized, open-label, single-dose, two-sequence, two-period, double-crossover bioequivalence study of vonoprazan fumarate tablets (20 mg) in Chinese healthy subjects under fasting and fed conditions
主要研究目的:按有关生物等效性试验的规定,选择Takeda Pharmaceutical Company Limited为持证商的富马酸伏诺拉生片(商品名:Vocinti(沃克),规格:20mg)为参比制剂,对浙江东亚药业股份有限公司生产的受试制剂富马酸伏诺拉生片(规格:20mg)进行空腹和餐后条件下给药的人体生物等效性试验,比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内,评价两种制剂在空腹和餐后给药条件下的生物等效性。
次要研究目的:观察健康受试者口服受试制剂富马酸伏诺拉生片(规格:20mg)和参比制剂富马酸伏诺拉生片(商品名:Vocinti(沃克),规格:20mg)的安全性。
[Translation] Main purpose of study: According to the relevant provisions of bioequivalence test, Takeda Pharmaceutical Company Limited was selected as the reference preparation for the human bioequivalence test of vonoprazan fumarate tablets (trade name: Vocinti (Walker), specification: 20mg), and the test preparation vonoprazan fumarate tablets (specification: 20mg) produced by Zhejiang East Asia Pharmaceutical Co., Ltd. was used for fasting and postprandial administration. The absorption rate and degree of the drug in the test preparation were compared with the reference preparation to see whether they were within the acceptable range, and the bioequivalence of the two preparations under fasting and postprandial administration conditions was evaluated.
Secondary purpose of study: To observe the safety of oral administration of the test preparation vonoprazan fumarate tablets (specification: 20mg) and the reference preparation vonoprazan fumarate tablets (trade name: Vocinti (Walker), specification: 20mg) in healthy subjects.
100 Clinical Results associated with Zhejiang East Asia Pharmaceutical Co., Ltd.
0 Patents (Medical) associated with Zhejiang East Asia Pharmaceutical Co., Ltd.
100 Deals associated with Zhejiang East Asia Pharmaceutical Co., Ltd.
100 Translational Medicine associated with Zhejiang East Asia Pharmaceutical Co., Ltd.