Delving into the Latest Updates on Zhengzhou Weixian Medical Technology Co., Ltd. with Synapse

Overview

"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甲磺酸沙芬酰胺片（规格：按C17H19FN2O2计，100mg；生产企业：深圳信立泰药业股份有限公司）和参比制剂甲磺酸沙非胺片（商品名：Xadago®；规格：按C17H19FN2O2计，100mg；持证商和生产企业：Zambon S.p.A.）后的药代动力学特征，评价空腹/餐后状态下两种制剂的生物等效性。次要目的：观察受试制剂甲磺酸沙芬酰胺片和参比制剂甲磺酸沙非胺片（Xadago®）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 safinamide mesylate tablets (specification: 100 mg based on C17H19FN2O2; manufacturer: Shenzhen Xinlitai Pharmaceutical Co., Ltd.) and the reference preparation safinamide mesylate tablets (trade name: Xadago®; specification: 100 mg based on C17H19FN2O2; licensee and manufacturer: Zambon S.p.A.) in Chinese healthy subjects after a single oral administration in the fasting/postprandial state, and to evaluate the bioequivalence of the two preparations in the fasting/postprandial state. Secondary objective: To observe the safety of the test preparation safinamide mesylate tablets and the reference preparation safinamide mesylate tablets (Xadago®) in Chinese healthy subjects."

Start Date17 Jun 2024

Sponsor / Collaborator

Zhengzhou Weixian Medical Technology Co., Ltd.

100 Clinical Results associated with Zhengzhou Weixian Medical Technology Co., Ltd.

Login to view more data

0 Patents (Medical) associated with Zhengzhou Weixian Medical Technology Co., Ltd.

Login to view more data

100 Deals associated with Zhengzhou Weixian Medical Technology Co., Ltd.

Login to view more data

100 Translational Medicine associated with Zhengzhou Weixian Medical Technology Co., Ltd.

Login to view more data