[Translation] Bioequivalence trial of sitagliptin metformin extended-release tablets
主要研究目的:
评价中国健康成年受试者空腹及餐后条件下单次单剂量口服西格列汀二甲双胍缓释片受试制剂(规格:以西格列汀/盐酸二甲双胍计100mg/1000mg,申办者:江苏谦仁生物科技有限公司)和参比制剂(商品名:Janumet®XR,规格:以西格列汀/盐酸二甲双胍计100mg/1000mg,持证商:Merck Sharp and Dohme Corp)后的药代动力学特点和生物等效性。
次要研究目的:
研究西格列汀二甲双胍缓释片受试制剂(规格:以西格列汀/盐酸二甲双胍计100mg/1000mg)和参比制剂(商品名:Janumet®XR,规格:以西格列汀/盐酸二甲双胍计100mg/1000mg)在中国健康成年受试者中的安全性。
[Translation] Main research purposes:
Evaluation of the test preparation of sitagliptin and metformin sustained-release tablets administered as a single oral dose to Chinese healthy adult subjects under fasting and postprandial conditions (specification: 100 mg/1000 mg based on sitagliptin/metformin hydrochloride, sponsor: Jiangsu Qianren Biotechnology Co., Ltd.) and the reference preparation (trade name: Janumet® Equivalence.
Secondary research purpose:
Study sitagliptin metformin extended-release tablets test preparation (specification: 100 mg/1000 mg based on sitagliptin/metformin hydrochloride) and reference preparation (trade name: Janumet®XR, specification: 100 mg based on sitagliptin/metformin hydrochloride) /1000mg) in healthy Chinese adult subjects.
[Translation] Bioequivalence trial of mesalazine enteric-coated tablets
主要研究目的
评价中国健康成年受试者空腹及餐后条件下单次单剂量口服美沙拉秦肠溶片受试制剂(规格:0.5g,申办者:江苏谦仁生物科技有限公司)和参比制剂(商品名:Salofalk®,规格:0.5g,持证商:Dr.Falk Pharma GmbH)后的药代动力学特点和生物等效性。
次要研究目的
研究美沙拉秦肠溶片受试制剂(规格:0.5g)和参比制剂(商品名:Salofalk®,规格:0.5g)在中国健康成年受试者中的安全性。
[Translation] Main research purpose
Evaluation of the test preparation (specification: 0.5g, sponsor: Jiangsu Qianren Biotechnology Co., Ltd.) and reference preparation (commercial product) of mesalazine enteric-coated tablets administered as a single dose to Chinese healthy adult subjects under fasting and postprandial conditions Name: Salofalk®, Specification: 0.5g, Licensee: Dr. Falk Pharma GmbH) after the pharmacokinetic characteristics and bioequivalence.
Secondary research purpose
To study the safety of mesalazine enteric-coated tablets test preparation (specification: 0.5g) and reference preparation (trade name: Salofalk®, specification: 0.5g) in healthy adult subjects in China.
[Translation] Bioequivalence test of eperisone hydrochloride tablets
主要研究目的
评价中国健康成年受试者空腹及餐后条件下单次单剂量口服盐酸乙哌立松片受试制剂(规格:50mg,申办者:江苏谦仁生物科技有限公司)和参比制剂(商品名:妙纳®,规格:50mg,持证商:卫材(中国)药业有限公司)后的药代动力学特点和生物等效性。
次要研究目的
研究盐酸乙哌立松片受试制剂(规格:50mg)和参比制剂(商品名:妙纳®,规格:50mg)在中国健康成年受试者中的安全性。
[Translation] Main research purpose
Evaluation of the test preparation (specification: 50 mg, sponsor: Jiangsu Qianren Biotechnology Co., Ltd.) and the reference preparation (trade name: The pharmacokinetic characteristics and bioequivalence of Myona®, specification: 50mg, license holder: Eisai (China) Pharmaceutical Co., Ltd.).
Secondary research purpose
To study the safety of the test preparation (specification: 50mg) and reference preparation (trade name: Miona®, specification: 50mg) of eperisone hydrochloride tablets in healthy adult subjects in China.
100 Clinical Results associated with Jiangsu Qianren Biotechnology Co. Ltd.
0 Patents (Medical) associated with Jiangsu Qianren Biotechnology Co. Ltd.
100 Deals associated with Jiangsu Qianren Biotechnology Co. Ltd.
100 Translational Medicine associated with Jiangsu Qianren Biotechnology Co. Ltd.