Delving into the Latest Updates on Waterstone Pharmaceuticals (HuBei) Co., Ltd. with Synapse

Overview

Basic Info

Introduction

Founded in 2009, Huashitong Biopharmaceutical Technology (Wuhan) Co., Ltd was jointly initiated by multinational pharmaceutical executives and a team of overseas-educated PhDs. The company is dedicated to the research and production of drugs for metabolic diseases such as diabetic kidney disease. The company has set up a production base for polymer drug intermediates, raw materials, and high-end formulations, as well as a platform for the screening of polymer drugs and medical materials.

主要目的：评估WS012在中国健康成人受试者中单次和多次口服给药的安全性和耐受性。次要目的：评估WS012在中国健康成人受试者中单次和多次口服给药的总胆汁酸（TBA）和粪便中TBA的药效动力学。探索性目的：探索健康受试者多次口服给药WS012对血脂（TG、TC、HDL-C、LDL-C）的影响。

[Translation]

Primary objective: To evaluate the safety and tolerability of WS012 after single and multiple oral administration in healthy Chinese adult subjects. Secondary objective: To evaluate the pharmacodynamics of total bile acid (TBA) and fecal TBA in WS012 after single and multiple oral administration in healthy Chinese adult subjects. Exploratory objective: To explore the effects of multiple oral administration of WS012 on blood lipids (TG, TC, HDL-C, LDL-C) in healthy subjects.

Start Date04 Jan 2024

Sponsor / Collaborator

Waterstone Pharmaceuticals (HuBei) Co., Ltd.

[+1]

CTR20212589

/ CompletedNot Applicable

他达拉非片在健康男性受试者中随机、开放、两制剂、单次给药、两周期、双交叉、空腹和餐后状态下的生物等效性试验

[Translation] A randomized, open-label, two-formulation, single-dose, two-period, double-crossover, bioequivalence study of tadalafil tablets in healthy male subjects under fasting and fed conditions

以湖北华世通生物医药科技有限公司生产的他达拉非片为受试制剂，按生物等效性研究的有关规定，与Lilly del Caribe, Inc.生产的他达拉非片（商品名：希爱力®）对比在健康人体内的吸收速度和吸收程度，考察两制剂的人体生物等效性研究。次要目的：观察受试制剂他达拉非片和参比制剂他达拉非片（希爱力®）在健康受试者中的安全性。

[Translation]

Tadalafil tablets produced by Hubei Huashitong Biopharmaceutical Technology Co., Ltd. were used as the test preparation. According to the relevant provisions of bioequivalence studies, the absorption rate and degree of tadalafil tablets (trade name: Cialis®) produced by Lilly del Caribe, Inc. were compared in healthy humans to investigate the bioequivalence of the two preparations. Secondary objective: To observe the safety of the test preparation tadalafil tablets and the reference preparation tadalafil tablets (Cialis®) in healthy subjects.

Start Date18 Nov 2021

Sponsor / Collaborator

Waterstone Pharmaceuticals (HuBei) Co., Ltd.

CTR20202568

/ CompletedNot Applicable

他达拉非片在健康男性受试者中随机、开放、两制剂、单次给药、两周期、双交叉、空腹和餐后状态下的生物等效性试验

[Translation] A randomized, open-label, two-formulation, single-dose, two-period, double-crossover, bioequivalence study of tadalafil tablets in healthy male subjects under fasting and fed conditions

主要目的：以湖北华世通生物医药科技有限公司生产的他达拉非片为受试制剂，按生物等效性研究的有关规定，与Lilly del Caribe, Inc.生产的他达拉非片（商品名：希爱力®）对比在健康人体内的吸收速度和吸收程度，考察两制剂的人体生物等效性研究。次要目的：观察受试制剂他达拉非片和参比制剂他达拉非片（希爱力®）在健康受试者中的安全性。

[Translation]

Primary objective: To compare the absorption rate and extent of tadalafil tablets produced by Hubei Huashitong Biopharmaceutical Technology Co., Ltd. with tadalafil tablets (trade name: Cialis®) produced by Lilly del Caribe, Inc. in healthy human bodies, and to investigate the bioequivalence of the two preparations. Secondary objective: To observe the safety of the test preparation tadalafil tablets and the reference preparation tadalafil tablets (Cialis®) in healthy subjects.

Start Date13 Jan 2021

Sponsor / Collaborator

Waterstone Pharmaceuticals (HuBei) Co., Ltd.

100 Clinical Results associated with Waterstone Pharmaceuticals (HuBei) Co., Ltd.

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