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MechanismMAO-B inhibitors |
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Drug Highest PhaseApproved |
First Approval Ctry. / Loc. |
First Approval Date21 Feb 2005 |
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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.United States |
First Approval Date06 Apr 1955 |
Target- |
Mechanism- |
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Active Indication- |
Inactive Indication- |
Drug Highest PhaseIND Application |
First Approval Ctry. / Loc.- |
First Approval Date- |
/ Active, not recruitingNot Applicable [Translation] Human bioequivalence study of baricitinib tablets
主要目的:
本试验旨在研究单次空腹口服上海上药中西制药有限公司研制、生产的巴瑞替尼片(2 mg)的药代动力学特征;以 Lilly del Caribe, Inc.生产的巴瑞替尼片(艾乐明®,2 mg)为参比制剂,比较两制剂中药动学参数 Cmax、AUC0-t、AUC0-∞,评价两制剂的人 体生物等效性。
次要目的:
评价空腹条件下,受试制剂与参比制剂在中国健康参与者体内的安全性。
[Translation] Primary Objective: This study aimed to investigate the pharmacokinetic characteristics of baricitinib tablets (2 mg) manufactured by Shanghai Shangyao Zhongxi Pharmaceutical Co., Ltd., after a single oral fasting administration. Baricitinib tablets (Ailemin®, 2 mg) manufactured by Lilly del Caribe, Inc. were used as the reference formulation. The pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two formulations were compared to evaluate their human bioequivalence.
Secondary Objective: To evaluate the safety of the test formulation and the reference formulation in healthy Chinese participants under fasting conditions.
/ CompletedNot Applicable [Translation] Bioequivalence study of upadacitinib sustained-release tablets in healthy volunteers
主要目的:
比较空腹和餐后给药条件下受试制剂上海上药中西制药有限公司提供的乌帕替尼缓释片(规格:15 mg)与参比制剂AbbVie Deutschland GmbH & Co. KG持证的乌帕替尼缓释片(商品名:RINVOQ(瑞福)®;规格:15 mg)在中国健康人群吸收程度和吸收速度的差异,评价两制剂的生物等效性。
次要目的:
评价空腹及餐后条件下,受试制剂与参比制剂在中国健康参与者体内的安全性。
[Translation] Primary Objective:
To compare the extent and rate of absorption of the test formulation, upadacitinib extended-release tablets (15 mg) provided by Shanghai Pharma Zhongxi Pharmaceutical Co., Ltd., and the reference formulation, upadacitinib extended-release tablets (RINVOQ®; 15 mg) licensed by AbbVie Deutschland GmbH & Co. KG, in healthy Chinese subjects under fasting and fed conditions, and to evaluate the bioequivalence of the two formulations.
Secondary Objective:
To evaluate the safety of the test formulation and the reference formulation in healthy Chinese subjects under fasting and fed conditions.
醋酸艾司利卡西平片在中国健康成人受试者中的药动学研究
[Translation] Pharmacokinetic study of eslicarbazepine acetate tablets in healthy Chinese adults
单次给药主要研究目的:考察中国健康受试者在空腹条件下,单次口服不同剂量水平的醋酸艾司利卡西平片的药代动力学(Pharmacokinetics, PK)特征和PK种族敏感性。
多次给药主要研究目的:考察中国健康受试者在空腹条件下,多次口服同一剂量的醋酸艾司利卡西平片的药代动力学(Pharmacokinetics, PK)特征。
[Translation] The main purpose of single-dose administration is to investigate the pharmacokinetic (PK) characteristics and PK ethnic sensitivity of eslicarbazepine acetate tablets at different dose levels in Chinese healthy subjects under fasting conditions.
The main purpose of multiple-dose administration is to investigate the pharmacokinetic (PK) characteristics of eslicarbazepine acetate tablets at the same dose in Chinese healthy subjects under fasting conditions.
100 Clinical Results associated with Shanghai Shangyao Chinese-Western Pharmaceutical Co., Ltd
0 Patents (Medical) associated with Shanghai Shangyao Chinese-Western Pharmaceutical Co., Ltd
100 Deals associated with Shanghai Shangyao Chinese-Western Pharmaceutical Co., Ltd
100 Translational Medicine associated with Shanghai Shangyao Chinese-Western Pharmaceutical Co., Ltd