[Translation] A single-center, randomized, open-label, single-dose (fasting/postprandial) oral administration, two-formulation, two-sequence, two-period, crossover human bioequivalence trial of acetazolamide tablets in healthy participants in China.

主要目的:观察中国健康试验参与者在空腹/餐后状态下单次口服受试制剂乙酰唑胺片(规格:0.25g;持证商和生产企业:石家庄格瑞药业有限公司)和参比制剂乙酰唑胺片(商品名:Diamox;规格:0.25g;持证商和生产企业:Sanwa Kagaku Kenkyusho Co.,Ltd.)后的药代动力学特征,初步评价空腹/餐后状态下两种制剂的生物等效性,为正式试验提供依据。次要目的:观察受试制剂乙酰唑胺片和参比制剂乙酰唑胺片(Diamox)在中国健康试验参与者中的安全性。

[Translation]

Primary Objective: To observe the pharmacokinetic characteristics of the test formulation acetazolamide tablets (0.25g; manufacturer and licensee: Shijiazhuang Green Pharmaceutical Co., Ltd.) and the reference formulation acetazolamide tablets (trade name: Diamox; 0.25g; manufacturer and licensee: Sanwa Kagaku Kenkyusho Co., Ltd.) after a single oral dose in Chinese healthy participants under fasting/postprandial conditions, and to preliminarily evaluate the bioequivalence of the two formulations under fasting/postprandial conditions, providing a basis for formal trials. Secondary Objective: To observe the safety of the test formulation acetazolamide tablets and the reference formulation acetazolamide tablets (Diamox) in Chinese healthy participants.

Start Date13 Apr 2026

Sponsor / Collaborator

Shijiazhuang Green Pharmaceutical Co., Ltd.

CTR20252659

/ RecruitingNot Applicable

普罗布考片在健康受试者中随机、开放、单次给药、三周期、部分重复空腹/餐后状态下的生物等效性试验

[Translation] A randomized, open-label, single-dose, three-period, partially repeated bioequivalence study of probucol tablets in healthy subjects under fasting/fed conditions

主要研究目的：研究空腹/餐后状态下单次口服受试制剂普罗布考片（规格：0.25g，石家庄格瑞药业有限公司持证）与参比制剂普罗布考片（商品名：Lorelco®，规格：0.25g；大塚製薬株式会社持证）在健康成年受试者体内的生物等效性。次要研究目的：研究受试制剂和参比制剂在健康成年受试者中的安全性。

[Translation]

The main purpose of the study is to study the bioequivalence of the test preparation Probucol Tablets (Specification: 0.25g, licensed by Shijiazhuang Grey Pharmaceutical Co., Ltd.) and the reference preparation Probucol Tablets (Trade name: Lorelco®, Specification: 0.25g; licensed by Otsuka Pharmaceutical Co., Ltd.) in healthy adult subjects after a single oral administration in the fasting/postprandial state. The secondary purpose of the study is to study the safety of the test preparation and the reference preparation in healthy adult subjects.

Start Date12 Aug 2025

Sponsor / Collaborator

Shijiazhuang Green Pharmaceutical Co., Ltd.

CTR20252168

/ CompletedNot Applicable

美阿沙坦钾片在中国健康受试者中进行的单中心、随机、开放、单次(空腹/餐后)口服给药、两制剂、两序列、两周期、交叉的人体生物等效性试验

[Translation] A single-center, randomized, open-label, single-dose (fasting/postprandial) oral bioequivalence study of Asartan Potassium Tablets in healthy Chinese subjects.

主要目的:观察中国健康受试者在空腹/餐后状态下单次口服受试制剂美阿沙坦钾片(规格:按美阿沙坦(C30H24N4O8)计 80mg;生产企业:石家庄格瑞药业有限公司)和参比制剂美阿沙坦钾片(商品名:易达比(EDARBI);规格:按美阿沙坦(C30H24N4O8)计 80mg;持证商:Takeda Pharma A/S)后的药代动力学特征,评价空腹/餐后状态下两种制剂在健康受试者体内的生物等效性。次要目的:观察受试制剂美阿沙坦钾片和参比制剂美阿沙坦钾片(易达比(EDARBI))在中国健康受试者中的安全性。

[Translation]

Primary objective: To observe the pharmacokinetic characteristics of the test preparation, Asartan Potassium Tablets (Specification: 80 mg based on Asartan (C30H24N4O8); Manufacturer: Shijiazhuang Grey Pharmaceutical Co., Ltd.) and the reference preparation, Asartan Potassium Tablets (Trade name: EDARBI; Specification: 80 mg based on Asartan (C30H24N4O8); Licensee: Takeda Pharma A/S) in healthy Chinese subjects after a single oral administration in the fasting/fed state, and to evaluate the bioequivalence of the two preparations in healthy subjects in the fasting/fed state. Secondary objective: To observe the safety of the test preparation, Asartan Potassium Tablets and the reference preparation, Asartan Potassium Tablets (EDARBI) in healthy Chinese subjects.

Start Date01 Jul 2025

Sponsor / Collaborator

Shijiazhuang Green Pharmaceutical Co., Ltd.

100 Clinical Results associated with Shijiazhuang Green Pharmaceutical Co., Ltd.

0 Patents (Medical) associated with Shijiazhuang Green Pharmaceutical Co., Ltd.

100 Deals associated with Shijiazhuang Green Pharmaceutical Co., Ltd.

100 Translational Medicine associated with Shijiazhuang Green Pharmaceutical Co., Ltd.

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