[Translation] A single-center, randomized, open-label, single-dose, two-sequence, two-period, double-crossover bioequivalence study of ubenimex capsules (30 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Nippon Kayaku Co., Ltd.为持证商的乌苯美司胶囊（商品名：Bestatin，规格：30mg）为参比制剂，对西安万隆制药股份有限公司生产并提供的受试制剂乌苯美司胶囊（规格：30mg）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，评估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：观察健康志愿受试者口服受试制剂乌苯美司胶囊（规格：30mg）和参比制剂乌苯美司胶囊（商品名：Bestatin，规格：30mg）的安全性。

[Translation]

Main purpose of study: According to the relevant provisions of bioequivalence test, Nippon Kayaku Co., Ltd. is the licensee of Ubenimex Capsules (trade name: Bestatin, specification: 30mg) as the reference preparation, and the test preparation Ubenimex Capsules (specification: 30mg) produced and provided by Xi'an Wanlong Pharmaceutical Co., Ltd. are conducted on fasting and postprandial human bioequivalence tests to compare whether the absorption rate and degree of the drug in the test preparation are within the acceptable range with the reference preparation, and to evaluate the bioequivalence of the two preparations under fasting and postprandial administration conditions. Secondary purpose of study: To observe the safety of oral administration of the test preparation Ubenimex Capsules (specification: 30mg) and the reference preparation Ubenimex Capsules (trade name: Bestatin, specification: 30mg) by healthy volunteers.

Start Date11 Oct 2023

Sponsor / Collaborator

Xian Wanlong Pharmaceutical Co. Ltd.

CTR20211293 / CompletedNot Applicable

奥硝唑胶囊（0.25g）在中国健康受试者中空腹和餐后给药条件下、单中心、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 single-center, randomized, open-label, single-dose, two-sequence, two-period, double-crossover bioequivalence study of ornidazole capsules (0.25 g) 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OrPha Swiss GmbH为持证商的奥硝唑片（商品名：Tiberal®，规格：0.5g）为参比制剂，对西安万隆制药股份有限公司生产的受试制剂奥硝唑胶囊（规格：0.25g）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及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奥硝唑胶囊（规格：0.25g）和参比制剂奥硝唑片（商品名：Tiberal®，规格：0.5g）的安全性。

[Translation]

Main research purpose: According to the relevant provisions of bioequivalence test, Ornidazole Tablets (trade name: Tiberal®, specification: 0.5g) produced by OrPha Swiss GmbH was selected as the reference preparation, and the test preparation Ornidazole Capsules (specification: 0.25g) produced by Xi'an Wanlong Pharmaceutical Co., Ltd. were tested for fasting and postprandial administration in humans, 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 and postprandial administration conditions. Secondary research purpose: To observe the safety of oral administration of the test preparation Ornidazole Capsules (specification: 0.25g) and the reference preparation Ornidazole Tablets (trade name: Tiberal®, specification: 0.5g) by healthy volunteers.

Start Date27 Jun 2021

Sponsor / Collaborator

Xian Wanlong Pharmaceutical Co. Ltd.

CTR20211294 / CompletedNot Applicable

评估受试制剂依帕司他片（规格：50 mg）与参比制剂依帕司他片（Kinedak®）（规格：50 mg）在健康成年受试者空腹状态下的单中心、开放、随机、单剂量、两周期、两序列、交叉生物等效性研究

[Translation] A single-center, open-label, randomized, single-dose, two-period, two-sequence, crossover bioequivalence study to evaluate the bioequivalence of the test formulation epalrestat tablets (strength: 50 mg) and the reference formulation epalrestat tablets (Kinedak®) (strength: 50 mg) in healthy adult subjects under fasting conditions

主要试验目的：研究空腹状态下单次口服受试制剂依帕司他片（规格：50 mg，西安万隆制药股份有限公司生产）与参比制剂依帕司他片（Kinedak®，规格：50 mg；日本小野薬品工業株式会社(Ono Pharmaceutical Co., Ltd)生产）在健康成年受试者体内的药代动力学特征，评价空腹状态口服两种制剂的生物等效性。次要试验目的：研究受试制剂依帕司他片（规格：50 mg）与参比制剂依帕司他片（Kinedak®）（规格：50 mg）在健康成年受试者中的安全性。

[Translation]

Main purpose of the test: To study the difference between the test preparation Epalrestat Tablets (specification: 50 mg, produced by Xi'an Wanlong Pharmaceutical Co., Ltd.) and the reference preparation Epalrestat Tablets (Kinedak®, specification: 50) in a fasting state. mg; produced by Ono Pharmaceutical Co., Ltd.) in healthy adult subjects to evaluate the bioequivalence of the two oral preparations in the fasting state. Secondary trial purpose: To study the safety of the test preparation epalrestat tablets (specification: 50 mg) and the reference preparation epalrestat tablets (Kinedak®) (specification: 50 mg) in healthy adult subjects.

Start Date25 May 2021

Sponsor / Collaborator

Xian Wanlong Pharmaceutical Co. Ltd.

100 Clinical Results associated with Xian Wanlong Pharmaceutical Co. Ltd.

0 Patents (Medical) associated with Xian Wanlong Pharmaceutical Co. Ltd.

Literatures (Medical) associated with Xian Wanlong Pharmaceutical Co. Ltd.

Jingxi Yu Zhuanyong Huaxuepin

Research progress in analysis and detection of caprolactam in multiple fields

Author: Men, Jing ; Li, Juan ; Zhang, Liang-liang ; Niu, Guo-long ; Tian, Zhen-zhen ; Liu, Zhao ; Nan, Long-wei ; Sun, Hua-li ; Li, Cheng-bin

The research progress in anal. and detection of caprolactam in the fields of food, water industry, pharmaceutical preparations, traditional Chinese medicine extracts, plastic products, human metabolites in recent years was reviewed, relatively novel detection examples were reported, and the development prospect was put forwarded.

Jingxi Shiyou Huagong Jinzhan

Progress in the analysis and detection technology of trace propylene oxide

Author: Tang, Xiaoqin ; Yan, Xiaoyu ; Wang, Dan ; Kang, Zhanguo ; Liu, Zhao ; Zhang, Zhen ; Ma, Lan

Propylene oxide belongs to class 2B carcinogen, which will cause certain harm to organism and environment.The anal. and testing methods of propylene oxide in recent years, such as gas chromatog., gas chromatog.-mass spectrometry, Raman spectroscopy, catalytic luminescence sensor were reviewed.The advantages and disadvantages of different detection methods were described.At the same time, the application status of these anal. and testing methods in atm. environment, textiles, tobacco products, surfactants and other fields was summarized.It has certain reference significance for the development of efficient and convenient propylene oxide anal. and detection technol.

Zhejiang Huagong

Determination of residual solvent formic acid content in febuxostat by gas chromatography with pre-column derivatization

Author: Li, Xiaoning ; Zhao, Min ; Men, Jing ; Jiang, Yanling

Objective: A method for determining formic acid content of febuxostat residual solvent by pre-column derivatization-gas chromatog. was established.Methods: DB-WAX UI (30 m×0.25 mm×0.5 μm) column was used with hydrogen flame ion detector (FID).The detector temperature was 230°C.Results: The formic acid resolution was good, the linear relationship was good in the concentration range of 2.5∼500.0 μg/mL (r=0.9999), the limit of quantification was 2.5 μg/mL, the detection limit was 0.7 μg/mL, the average recovery rate was 97.8%, the RSD was 1.9%, and the test solution was stable.Organic solvent formic acid was detected in 3 batches of samples of febuxostat API, and the test results all met the limit of formic acid (not exceeding 0.5%).Conclusion: This method is simple to operate, accurate and reliable, and has high sensitivity, which is suitable for the anal. and detection of formic acid residual solvent in febuxostat APIs.

100 Deals associated with Xian Wanlong Pharmaceutical Co. Ltd.

100 Translational Medicine associated with Xian Wanlong Pharmaceutical Co. Ltd.

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