[Translation] Bioequivalence trial of roxadustat capsules in healthy adult subjects
主要研究目的:研究重庆煜洋药业有限公司持有,重庆圣华曦药业股份有限公司生产的罗沙司他胶囊(规格:50mg)在中国健康受试者中空腹状态及高脂餐后以口服途径单次给药的药代动力学特征,并以珐博进(中国)医药技术开发有限公司生产的罗沙司他胶囊(商品名:爱瑞卓®;规格:50mg)为参比制剂,进行生物等效性评价。次要研究目的:初步考察罗沙司他胶囊受试制剂和参比制剂在健康受试者中的安全性。
[Translation] Main research purpose: To study the effect of roxadustat capsules (specification: 50mg) held by Chongqing Yuyang Pharmaceutical Co., Ltd. and produced by Chongqing Shenghuaxi Pharmaceutical Co., Ltd. in Chinese healthy subjects on an empty stomach and after a high-fat meal. Pharmacokinetic characteristics of a single dose by oral route, and roxadustat capsules (trade name: Arridro®; specification: 50 mg) produced by Fabojin (China) Pharmaceutical Technology Development Co., Ltd. as a reference preparations and conduct bioequivalence evaluation. Secondary research purpose: Preliminarily investigate the safety of the test preparation and reference preparation of roxadustat capsules in healthy subjects.
[Translation] Bioequivalence test of benidipine hydrochloride tablets in healthy adult subjects
主要研究目的:研究重庆煜洋药业有限公司持有,重庆圣华曦药业股份有限公司生产的盐酸贝尼地平片(规格:4 mg)在中国健康受试者中空腹状态及高脂餐后以口服途径单次给药的药代动力学特征,并以日本协和发酵麒麟株式会社/Kyowa Kirin Co., Ltd.持有,Kyowa Kirin Co., Ltd.Ube Plant 生产的盐酸贝尼地平片(商品名:可力洛®(Coniel®);规格:4 mg)为参比制剂,进行生物等效性评价。次要研究目的:考察盐酸贝尼地平片受试制剂和参比制剂在健康受试者中的安全性。
[Translation] The main research purpose: To study the pharmacokinetic characteristics of benidipine hydrochloride tablets (specification: 4 mg) held by Chongqing Yuyang Pharmaceutical Co., Ltd. and produced by Chongqing Shenghuaxi Pharmaceutical Co., Ltd. in Chinese healthy subjects in the fasting state and oral administration after a high-fat meal. Benidipine hydrochloride tablets (trade name: Coniel® (Coniel®; specification: 4 mg) was used as the reference preparation for bioequivalence evaluation. Secondary research purpose: To investigate the safety of Benidipine Hydrochloride Tablets test preparation and reference preparation in healthy subjects.
100 Clinical Results associated with Chongqing Yuyang Pharmaceutical Co., Ltd.
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