[Translation] A fasting, single-dose, randomized, open-label, two-dose, two-period, double-crossover bioequivalence study of dexamethasone palmitate injection in healthy volunteers

主要目的：考察中国健康受试者在空腹条件下单剂量静脉注射江苏迪赛诺制药有限公司生产，河南利华制药有限公司持有的地塞米松棕榈酸酯注射液（规格：1ml:4mg（以地塞米松棕榈酸酯计））与由Mitsubishi Tanabe Pharma Korea Co., Ltd.生产，Mitsubishi Tanabe Pharma Corporation持有的地塞米松棕榈酸酯注射液（规格：1ml:4mg（以地塞米松棕榈酸酯计））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：评价单剂量静脉注射地塞米松棕榈酸酯注射液（规格：1ml:4mg（以地塞米松棕榈酸酯计））受试制剂及参比制剂在中国健康受试者中的安全性。

[Translation]

Primary objective: To investigate the in vivo pharmacokinetic characteristics of dexamethasone palmitate injection (specification: 1ml:4mg (dexamethasone palmitate)) produced by Jiangsu Desano Pharmaceutical Co., Ltd. and owned by Henan Lihua Pharmaceutical Co., Ltd. and dexamethasone palmitate injection (specification: 1ml:4mg (dexamethasone palmitate)) produced by Mitsubishi Tanabe Pharma Korea Co., Ltd. and owned by Mitsubishi Tanabe Pharma Corporation in healthy Chinese subjects under fasting conditions, and to evaluate the bioequivalence of the two preparations. Secondary objective: To evaluate the safety of the test preparation and reference preparation of single-dose intravenous dexamethasone palmitate injection (specification: 1ml:4mg (dexamethasone palmitate)) in healthy Chinese subjects.

Start Date12 Feb 2025

Sponsor / Collaborator

Henan Lihua Pharmaceutical Co. Ltd.

100 Clinical Results associated with Henan Lihua Pharmaceutical Co. Ltd.

0 Patents (Medical) associated with Henan Lihua Pharmaceutical Co. Ltd.

Literatures (Medical) associated with Henan Lihua Pharmaceutical Co. Ltd.

Huaxue Yu Shengwu Gongcheng

New Synthetic Process of Clobetasol Propionate

Author: Wang Ruiling ; Chen Yuzhen ; Li Hexing ; Wang Haibo

Using DB11 as a staring material, we obtained the intermediate through the three-step reaction of sulfonation-chloro-propionylation by a one-pot method.Then we synthesized Clobetasol propionate with the total yield of 81% and HPLC purity of more than 99% through the reactions of fluorination and refine.The structure of Clobetasol propionate is confirmed by ∼1HNMR and ESI-MS.

100 Deals associated with Henan Lihua Pharmaceutical Co. Ltd.

100 Translational Medicine associated with Henan Lihua Pharmaceutical Co. Ltd.

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