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[Translation] Bioequivalence study of pramipexole hydrochloride tablets in humans
以赤峰赛林泰药业有限公司提供的盐酸普拉克索片为受试制剂,按生物等效性试验的有关规定,与Boehringer Ingelheim Pharma GmbH生产的盐酸普拉克索片(商品名:森福罗®,参比制剂)对比在中国健康成年人体内的吸收速度及吸收程度,考察两制剂的人体生物等效性。
[Translation] Pramipexole hydrochloride tablets provided by Chifeng Sailintai Pharmaceutical Co., Ltd. were used as the test preparation. According to the relevant provisions of the bioequivalence study, the absorption rate and extent of pramipexole hydrochloride tablets (trade name: Senforo®, reference preparation) produced by Boehringer Ingelheim Pharma GmbH were compared in healthy Chinese adults to investigate the bioequivalence of the two preparations.
[Translation] Bioequivalence study of rosuvastatin calcium tablets in human subjects
主要研究目的
本试验的目的是以赤峰赛林泰药业有限公司提供的瑞舒伐他汀钙片为受试制剂,按有关生物等效性试验的规定,与IPR Pharmaceuticals, INCORPORATED生产(持证商:Astrazeneca UK Limited)的瑞舒伐他汀钙片(商品名:Crestor®,参比制剂)进行人体生物利用度与生物等效性试验。
次要研究目的
观察受试制剂瑞舒伐他汀钙片和参比制剂Crestor®在健康受试者中的安全性。
[Translation] Main study purpose
The purpose of this study is to use Rosuvastatin Calcium Tablets provided by Chifeng Sailintai Pharmaceutical Co., Ltd. as the test preparation, and conduct human bioavailability and bioequivalence tests with Rosuvastatin Calcium Tablets (trade name: Crestor®, reference preparation) produced by IPR Pharmaceuticals, INCORPORATED (licensee: Astrazeneca UK Limited) according to the relevant provisions of bioequivalence tests.
Secondary study purpose
Observe the safety of the test preparation Rosuvastatin Calcium Tablets and the reference preparation Crestor® in healthy subjects.
/ Not yet recruitingNot Applicable [Translation] Study on the bioequivalence of bismuth potassium citrate tablets in healthy volunteers
本试验旨在研究单次空腹口服赤峰赛林泰药业有限公司研制的枸橼酸铋钾片〔120mg(按Bi2O3 计) 〕的 药代动 力学特 征;以 TORA LABORATORIES, S.L. 生产 的枸橼 酸铋钾片〔Gastrodenol®,120mg(按 Bi2O3 计)〕为参比制剂,比较两制剂药动学参数 Cmax、AUC0-t、AUC0-∞,评价两制剂的人体生物等效性。
[Translation] The purpose of this study was to study the pharmacokinetic characteristics of a single fasting oral dose of bismuth potassium citrate tablets [120 mg (calculated as Bi2O3)] developed by Chifeng Sailintai Pharmaceutical Co., Ltd.; using bismuth potassium citrate tablets [Gastrodenol®, 120 mg (calculated as Bi2O3)] produced by TORA LABORATORIES, S.L. as the reference preparation, to compare the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations, and to evaluate the bioequivalence of the two preparations in humans.
100 Clinical Results associated with Chifeng Rongjitang Pharmaceutical Co. Ltd.
0 Patents (Medical) associated with Chifeng Rongjitang Pharmaceutical Co. Ltd.
100 Deals associated with Chifeng Rongjitang Pharmaceutical Co. Ltd.
100 Translational Medicine associated with Chifeng Rongjitang Pharmaceutical Co. Ltd.