托吡司特片治疗痛风伴高尿酸血症的随机、双盲、阳性药平行对照的剂量效应关系研究
[Translation] A randomized, double-blind, positive-drug parallel-controlled study on the dose-effect relationship of topiramate tablets in the treatment of gout with hyperuricemia
与别嘌醇对比,初步评估托吡司特片降低痛风患者尿酸水平的有效性及安全性。
[Translation] To preliminarily evaluate the effectiveness and safety of topiramate tablets in reducing uric acid levels in patients with gout compared with allopurinol.
/ CompletedNot Applicable [Translation] Bioequivalence study of pentoxifylline extended-release tablets in healthy participants
主要目的:本试验旨在研究空腹及餐后口服国药集团容生制药有限公司生产的己酮可可碱缓释片(400mg)的药代动力学特征,并以Snaofi S.r.l持证的己酮可可碱缓释片(Trental®,400mg)作为参比制剂,比较两制剂的药动学参数,评价两制剂的人体生物等效性。
次要目的:观察健康参与者口服受试制剂和参比制剂的安全性。
[Translation] Main purpose: This study aims to study the pharmacokinetic characteristics of fasting and postprandial oral administration of Pentoxifylline Sustained-Release Tablets (400 mg) produced by Sinopharm Rongsheng Pharmaceutical Co., Ltd., and to compare the pharmacokinetic parameters of the two preparations and evaluate the bioequivalence of the two preparations in humans using the Pentoxifylline Sustained-Release Tablets (Trental®, 400 mg) certified by Snaofi S.r.l as the reference preparation.
Secondary purpose: To observe the safety of the test preparation and the reference preparation in healthy participants.
/ CompletedNot Applicable [Translation] Bioequivalence study of nicorandil tablets in healthy subjects
本试验旨在研究空腹及餐后口服国药集团容生制药有限公司生产的尼可地尔片(5mg)的药代动力学特征,并以Chugai Pharmaceutical Co., Ltd.持证的尼可地尔片(喜格迈®,5mg)作为参比制剂,比较两制剂的药动学参数,评价两制剂的人体生物等效性。
[Translation] This study aimed to investigate the pharmacokinetic characteristics of nicorandil tablets (5 mg) produced by Rongsheng Pharmaceutical Co., Ltd. of China National Pharmaceutical Group after oral administration on an empty stomach or after meals, and to use nicorandil tablets (Sigma®, 5 mg) certified by Chugai Pharmaceutical Co., Ltd. as the reference preparation, to compare the pharmacokinetic parameters of the two preparations, and to evaluate the bioequivalence of the two preparations in humans.
100 Clinical Results associated with Guoyao Group Rongsheng Pharmaceutical Co. Ltd.
0 Patents (Medical) associated with Guoyao Group Rongsheng Pharmaceutical Co. Ltd.
100 Deals associated with Guoyao Group Rongsheng Pharmaceutical Co. Ltd.
100 Translational Medicine associated with Guoyao Group Rongsheng Pharmaceutical Co. Ltd.