[Translation] A randomized, open-label, two-period, double-crossover bioequivalence study of tinidazole tablets (500 mg) in healthy Chinese subjects after a single dose of food

主要研究目的：本研究以，湖北广济药业股份有限公司生产的替硝唑片(规格0.5g),Mission Pharmacal Company生产，Mikart inc Atlanta GA持证的替硝唑片（商品名：TINDAMAX®，规格：500mg/片）为参比制剂，评估受试制剂和参比制剂在餐后条件下给药时的生物等效性。次要研究目的：观察受试制剂和参比制剂在健康受试者中的安全性。

[Translation]

Primary study objective: This study uses tinidazole tablets (specification 0.5g) produced by Hubei Guangji Pharmaceutical Co., Ltd. and tinidazole tablets (trade name: TINDAMAX®, specification: 500mg/tablet) produced by Mission Pharmacal Company and licensed by Mikart inc Atlanta GA as reference preparations to evaluate the bioequivalence of the test preparation and the reference preparation when administered under postprandial conditions. Secondary study objective: To observe the safety of the test preparation and the reference preparation in healthy subjects.

Start Date27 Oct 2018

Sponsor / Collaborator

Hubei Guangji Pharmaceutical Co., Ltd.

CTR20181932 / Recruiting

恩替卡韦分散片在健康受试者中随机、开放、单剂量、两周期、两交叉、空腹状态下的生物等效性试验

[Translation] A randomized, open-label, single-dose, two-period, two-crossover, fasting bioequivalence study of entecavir dispersible tablets in healthy subjects

以湖北广济药业股份有限公司提供的恩替卡韦分散片为受试制剂，按生物等效性试验的有关规定，以BRISTOLMYERS SQUIBB生产的恩替卡韦片（BARACLUDE ® ）为参比制剂对比在健康人体内的相对生物利用度，考察两制剂的人体生物等效性。

[Translation]

Entecavir dispersible tablets provided by Hubei Guangji Pharmaceutical Co., Ltd. were used as the test preparation. According to the relevant regulations of the bioequivalence test, entecavir tablets (BARACLUDE ® ) produced by BRISTOLMYERS SQUIBB were used as the reference preparation to compare the relative bioavailability in healthy humans and investigate the human bioequivalence of the two preparations.

Start Date22 Oct 2018

Sponsor / Collaborator

Hubei Guangji Pharmaceutical Co., Ltd.

CTR20180890 / Not yet recruitingPhase 1

利奈唑胺片随机、开放、两周期、两交叉单次空腹及餐后状态下健康人体生物利用度和生物等效性试验

[Translation] A randomized, open-label, two-period, two-crossover single-dose bioavailability and bioequivalence study of linezolid tablets in healthy volunteers under fasting and fed conditions

①主要研究目的本试验的目的是以湖北广济药业股份有限公司提供的利奈唑胺片为受试制剂，按有关生物等效性试验的规定，与Pfizer Pharmaceuticals LLC.生产的利奈唑胺片（参比制剂）进行人体生物利用度与生物等效性试验。 ②次要研究目的观察受试制剂利奈唑胺片和参比制剂在健康受试者中的安全性。

[Translation]

①Main study objectives The purpose of this study is to use the linezolid tablets provided by Hubei Guangji Pharmaceutical Co., Ltd. as the test preparation, and conduct human bioavailability and bioequivalence tests with the linezolid tablets (reference preparation) produced by Pfizer Pharmaceuticals LLC. in accordance with the relevant provisions of bioequivalence tests. ②Secondary study objectives To observe the safety of the test preparation linezolid tablets and the reference preparation in healthy subjects.

Start Date17 Jun 2018

Sponsor / Collaborator

Hubei Guangji Pharmaceutical Co., Ltd.

100 Clinical Results associated with Hubei Guangji Pharmaceutical Co., Ltd.

0 Patents (Medical) associated with Hubei Guangji Pharmaceutical Co., Ltd.

News (Medical) associated with Hubei Guangji Pharmaceutical Co., Ltd.

13 Dec 2017

·www.bioportfolio.com

Global and Regional Riboflavin Market Research Report 2017 [Report Updated: 01122017] Prices from USD $3500

Summary Market Segment as follows: By Region AsiaPacific North America Europe South America Middle East Africa By Type Chemical Synthesis Microbial Fermentation By Application Food Feed Others By Company Roche BASF ADM Shanghai Yongxin Hubei Guangji Pharmaceutical Cangzhou Tianyu The main contents of the report including: Section 1: Product definition, type and application, global and regional market overview; Section 2: Global and regional Market competition by company; Section 3: Global and regional sales revenue, volume and price by type; Section 4: Global and regional sales revenue, volume and price by application; Section 5: Regional export and import; Section 6: Company information, business overview, sales data and product specifications; Section 7: Industry chain and raw materials; Section 8: SWOT and Porter's Five Forces; Section 9: Conclusion.

100 Deals associated with Hubei Guangji Pharmaceutical Co., Ltd.

100 Translational Medicine associated with Hubei Guangji Pharmaceutical Co., Ltd.

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