[Translation] A randomized, open-label, two-period, crossover, fasting/fed bioequivalence study of emedastine fumarate extended-release capsules in Chinese healthy volunteers

主要目的：在空腹/餐后状态下，考察四川德峰药业有限公司生产的富马酸依美斯汀缓释胶囊（受试制剂T，规格：2mg）与興和株式会社生产的富马酸依美斯汀缓释胶囊（参比制剂R，商品名：REMICUT®，规格：2mg）在中国健康成年受试者体内的药代动力学特征，评价两种制剂在空腹和餐后给药条件下的生物等效性。次要目的：观察受试制剂富马酸依美斯汀缓释胶囊和参比制剂富马酸依美斯汀缓释胶囊（REMICUT®）在中国健康成年受试者中的安全性。

[Translation]

Main purpose: To examine the relationship between emestine fumarate sustained-release capsules (test preparation T, specification: 2 mg) produced by Sichuan Defeng Pharmaceutical Co., Ltd. and fumarate produced by Xinghe Co., Ltd. in the fasting/postprandial state. Pharmacokinetic characteristics of emestine acid sustained-release capsules (reference preparation R, trade name: REMICUT®, strength: 2 mg) in healthy Chinese adult subjects, and evaluation of the two preparations administered on an empty stomach and after meals Bioequivalence under conditions. Secondary purpose: To observe the safety of the test formulation emedestine fumarate sustained-release capsules and the reference formulation emedestine fumarate sustained-release capsules (REMICUT®) in healthy adult subjects in China.

Start Date-

Sponsor / Collaborator

Sichuan Defeng Pharmaceutical Co., Ltd.

CTR20223345

/ RecruitingNot Applicable

富马酸依美斯汀缓释胶囊（2mg）在中国健康受试者中空腹和餐后给药条件下随机、开放、单剂量、两序列、两周期、双交叉生物等效性试验

[Translation] A randomized, open-label, single-dose, two-sequence, two-period, double-crossover bioequivalence study of emedastine fumarate extended-release capsules (2 mg) in Chinese healthy subjects under fasting and fed conditions

"主要研究目的：按有关生物等效性试验的规定，选择日本興和株式会社为持证商的富马酸依美斯汀缓释胶囊（商品名：REMICUT；规格：2mg）为参比制剂，对四川德峰药业有限公司生产提供的受试制剂富马酸依美斯汀缓释胶囊（规格：2mg）进行空腹和餐后给药人体生物等效性试验，比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内，评价两种制剂在空腹和餐后给药条件下的生物等效性。次要研究目的：观察中国健康受试者服用受试制剂富马酸依美斯汀缓释胶囊（规格：2mg）和参比制剂富马酸依美斯汀缓释胶囊（商品名：REMICUT；规格：2mg）后的安全性。

[Translation]

"Main research purpose: According to the regulations on bioequivalence testing, select emestine fumarate sustained-release capsules (trade name: REMICUT; specification: 2 mg) of Japan Kowa Co., Ltd. as the licensee as the reference preparation , conduct human bioequivalence tests on fasting and postprandial administration of the test preparation emestine fumarate sustained-release capsules (specification: 2 mg) produced and provided by Sichuan Defeng Pharmaceutical Co., Ltd., and compare the drugs in the test preparation Whether the difference in absorption rate and degree of absorption from the reference preparation is within the acceptable range, evaluate the bioequivalence of the two preparations under fasting and postprandial administration conditions. Secondary research purpose: To observe Chinese healthy subjects taking the test preparation emedestine fumarate sustained-release capsules (specification: 2 mg) and the reference preparation emedestine fumarate sustained-release capsules (trade name: REMICUT; Specification: 2mg) after safety.

Start Date02 Jan 2023

Sponsor / Collaborator

Sichuan Defeng Pharmaceutical Co., Ltd.

100 Clinical Results associated with Sichuan Defeng Pharmaceutical Co., Ltd.

0 Patents (Medical) associated with Sichuan Defeng Pharmaceutical Co., Ltd.

Literatures (Medical) associated with Sichuan Defeng Pharmaceutical Co., Ltd.

Jingxi Huagong (Dalian, China)

Solvent-free synthesis of 2-chloroethyl ethyl ether

Author: Zhang, Hongmo ; Yue, Zhiwei ; Mao, Yexiang ; Wu, Xiaochun ; He, Yong

The solvent-free synthesis process of 2-chloroethyl Et ether was improved in this research.Purified 2-chloroethyl Et ether was obtained from the reaction of 2-ethoxyethanol and thionyl chloride using triethylamine as catalyst, and a series of washing with saturated sodium bicarbonate solution, saturated sodium chloride solution and drying wi th anhydrous sodium sulfate.The structure of the sample produced was then characterized by ¹HNMR and GC-MS.The effects of molar ratio of reactants, reaction temperature and reaction time on the GC purity and yield of the product were further investigated via single factor exptl. anal.The optimized synthesis process of 2-chloroethyl Et ether was as follows:n (2-ethoxyethanol):n (thionyl chloride):n (triethylamine) =1.0:1.3:0.3, reaction temperature of 70°C, and reaction time of 4 h.Under the above conditions, the yield and GC purity of product was over 90.2% and 99.4%, resp., and the content was over 99.2% after kilogram scale pilot amplification.

100 Deals associated with Sichuan Defeng Pharmaceutical Co., Ltd.

100 Translational Medicine associated with Sichuan Defeng Pharmaceutical Co., Ltd.

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