[Translation] A randomized, open-label, single-dose, two-sequence, two-period, double-crossover bioequivalence study of aceclofenac tablets (100 mg) in Chinese healthy volunteers after meal administration

主要研究目的：按有关生物等效性试验的规定，选择Almirall, S.A.生产的醋氯芬酸片（商品名：AIRTAL®，规格：100mg/片）为参比制剂，对西安海欣制药有限公司生产的受试制剂醋氯芬酸片（规格：100mg/片）进行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，评价两种制剂在餐后给药条件下的生物等效性。次要研究目的：观察健康志愿受试者口服受试制剂醋氯芬酸片（规格：100mg/片）和参比制剂醋氯芬酸片（商品名：AIRTAL®，规格：100mg/片）的安全性。

[Translation]

Main research purpose: According to the relevant provisions of bioequivalence test, Aceclofenac Tablets (trade name: AIRTAL®, specification: 100 mg/tablet) produced by Almirall, S.A. was selected as the reference preparation, and the test preparation Aceclofenac Tablets (specification: 100 mg/tablet) produced by Xi'an Haixin Pharmaceutical Co., Ltd. was subjected to a human bioequivalence test after meal administration to compare whether the absorption rate and degree of the drug in the test preparation were within the acceptable range with the reference preparation, and to evaluate the bioequivalence of the two preparations under the condition of postprandial administration. Secondary research purpose: To observe the safety of oral administration of the test preparation Aceclofenac Tablets (specification: 100 mg/tablet) and the reference preparation Aceclofenac Tablets (trade name: AIRTAL®, specification: 100 mg/tablet) by healthy volunteers.

Start Date09 Sep 2021

Sponsor / Collaborator

Xi'an Haixin Pharmaceutical Co., Ltd

CTR20212086

/ CompletedNot Applicable

醋氯芬酸片（100mg）在中国健康受试者中空腹给药条件下随机、开放、单剂量、两序列、两周期、双交叉生物等效性试验

主要研究目的：按有关生物等效性试验的规定，选择Almirall， S.A.生产的醋氯芬酸片（商品名：AIRTAL®，规格：100mg/片）为参比制剂，对西安海欣制药有限公司生产的受试制剂醋氯芬酸片（规格：100mg/片）进行空腹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给药条件下的生物等效性。次要研究目的：观察健康志愿受试者口服受试制剂醋氯芬酸片（规格：100mg/片）和参比制剂醋氯芬酸片（商品名：AIRTAL®，规格：100mg/片）的安全性。

[Translation]

Main research purpose: According to the relevant provisions of bioequivalence test, Aceclofenac Tablets (trade name: AIRTAL®, specification: 100 mg/tablet) produced by Almirall, S.A. was selected as the reference preparation, and the test preparation Aceclofenac Tablets (specification: 100 mg/tablet) produced by Xi'an Haixin Pharmaceutical Co., Ltd. was used for fasting human bioequivalence test, to compare whether the absorption rate and degree of the drug in the test preparation were within the acceptable range with the reference preparation, and to evaluate the bioequivalence of the two preparations under fasting conditions. Secondary research purpose: To observe the safety of oral administration of the test preparation Aceclofenac Tablets (specification: 100 mg/tablet) and the reference preparation Aceclofenac Tablets (trade name: AIRTAL®, specification: 100 mg/tablet) by healthy volunteers.

Start Date04 Sep 2021

Sponsor / Collaborator

Xi'an Haixin Pharmaceutical Co., Ltd

CTR20191608

/ CompletedNot Applicable

硫酸羟氯喹片（硫酸羟氯喹，0.2 g，口服片剂）和Plaquenil（硫酸羟氯喹，0.2 g，口服片剂）的生物等效性研究

[Translation] Bioequivalence study of hydroxychloroquine sulfate tablets (hydroxychloroquine sulfate, 0.2 g, oral tablets) and Plaquenil (hydroxychloroquine sulfate, 0.2 g, oral tablets)

主要研究目的在健康男性和女性受试者中于空腹、餐后情况下评价硫酸羟氯喹片和Plaquenil® 的吸收速度和吸收程度，评价两制剂间是否具有生物等效性。次要研究目的评估受试制剂硫酸羟氯喹片和参比制剂Plaquenil® 在中国健康受试者中的安全性。

[Translation]

Primary study objective To evaluate the absorption rate and extent of hydroxychloroquine sulfate tablets and Plaquenil® in healthy male and female subjects under fasting and postprandial conditions, and to evaluate whether the two preparations are bioequivalent. Secondary study objective To evaluate the safety of the test preparation hydroxychloroquine sulfate tablets and the reference preparation Plaquenil® in healthy Chinese subjects.

Start Date04 Dec 2018

Sponsor / Collaborator

Xi'an Haixin Pharmaceutical Co., Ltd

100 Clinical Results associated with Xi'an Haixin Pharmaceutical Co., Ltd

0 Patents (Medical) associated with Xi'an Haixin Pharmaceutical Co., Ltd

Literatures (Medical) associated with Xi'an Haixin Pharmaceutical Co., Ltd

Xibei Yaoxue Zazhi

Green synthetic method of aniracetam

Author: Lu, Meili ; Wei, Qing ; Yin, Yan ; Chen, Xiaonan ; Sun, Lu

To promote the development of green chem., aniracetam (1) was synthesized from α-pyrrolidone (2) and p-methoxy-benzoic acid (4) via only one step.The structure of the product was confirmed by elemental anal. and IR spectrometry.The content and related substances of the product was detected by high performance liquid chromatog.This synthetic method was featured with a high atom utilization and lower pollution, which could be considered as a green synthetic method.

Xibei Yaoxue Zazhi

Study on dissolution method of aniracetam dispersible tablets

Author: Yan, Zhanshe ; Huang, Biao ; Dong, Kai ; Zhai, Fan ; Ma, Jibin

The aim of this study is to investigate the dissolution method of Aniracetam Dispersible Tablets.In order to determine the impact of different degassing way on the two dissolution methods, basket method and paddle method of Aniracetam Dispersible Tablets (MTT), basket method and paddle method were taken as the program, and the dissolution as the index.The different degassing way has greater impact on the basket method than on the paddle method during the determination of dissolutionThe data of paddle method to determine aniracetam dispersible tablets dissolution are reliable, and can effectively control the quality of the product.

Xibei Daxue Xuebao, Ziran Kexueban

Improvement for preparation process of Salvia miltiorrhiza injection

Author: Wang, Kai ; Huang, Biao ; Yan, Zhan-she

Improvement for preparation process of Salvia miltiorrhiza injection is studied in order to reduce the active constituents lost.The spray drying process was used in the preparation of Salvia miltiorrhiza injection.The effect of antioxidant vitamin C and sterilization to the active constituents in injection was evaluated.The time of preparation was reduced by using the spray drying process.The concentration of active constituent is improved.The spray drying process can protect the active ingredient in Salvia miltiorrhiza injection and ensure quality product.

100 Deals associated with Xi'an Haixin Pharmaceutical Co., Ltd

100 Translational Medicine associated with Xi'an Haixin Pharmaceutical Co., Ltd

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