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MechanismAKR1B1 inhibitors |
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Inactive Indication- |
Drug Highest PhasePhase 1 |
First Approval Ctry. / Loc.- |
First Approval Date- |
[Translation] Study on Bioequivalence of Epalrestat Tablets in Healthy Humans
主要试验目的:在中国健康受试者中单次空腹口服宁夏康亚药业股份有限公司生产的依帕司他片50 mg(规格:50 mg/片;受试制剂)和Ono Pharmaceutical Co., Ltd/アルフレッサファーマ株式会社(Alfresa Pharma Corporation)生产的依帕司他片50 mg(KINEDAK®,规格:50 mg/片;参比制剂)的生物等效性;
次要试验目的:观察受试制剂和参比制剂在健康受试者中的安全性。
[Translation] The main purpose of the trial is to give Chinese healthy subjects a single fasting oral dose of 50 mg epalrestat tablets produced by Ningxia Kangya Pharmaceutical Co., Ltd. (specification: 50 mg/tablet; test preparation) and Ono Pharmaceutical Co., Ltd/Alfresa Pharma Corporation (Alfresa Pharma Corporation) bioequivalence of epalrestat tablets 50 mg (KINEDAK®, specification: 50 mg/tablet; reference preparation);
Secondary test purpose: to observe the safety of the test preparation and reference preparation in healthy subjects.
WJ-39片在健康成人受试者中单次和多次给药的安全性、耐受性、药代动力学及食物影响的单中心、随机、双盲、安慰剂对照、剂量递增的I期临床研究
[Translation] A single-center, randomized, double-blind, placebo-controlled, dose-escalating I phase clinical study
主要目的:评价WJ-39片在健康受试者中单次和多次给药的耐受性及其产生的不良反应,确定安全耐受的人用剂量,评价食物对药物代谢的影响。
次要目的:探索WJ-39片在健康受试者中单次和多次给药的药代动力学特征,为制定本品的II期临床试验给药方案,提供安全的剂量范围。进行探索性物料平衡研究,考查WJ-39及其代谢物在血浆、尿液、粪便中的清除率。
[Translation] Main purpose: To evaluate the tolerance of single and multiple doses of WJ-39 tablets and its adverse reactions in healthy subjects, to determine the safe and tolerable human dose, and to evaluate the effect of food on drug metabolism.
Secondary purpose: To explore the pharmacokinetic characteristics of WJ-39 tablets in single and multiple doses in healthy subjects, and to provide a safe dose range for the formulation of the phase II clinical trial dosage regimen of this product. Carry out an exploratory material balance study to examine the clearance rates of WJ-39 and its metabolites in plasma, urine, and feces.
[Translation] Bioequivalence Study of Indapamide Sustained-Release Tablets in Healthy Humans (After Meal)
在中国健康受试者中评价单次餐后服用宁夏康亚药业股份有限公司生产的吲达帕胺缓释片(1.5mg×1片)和市售的Servier(Ireland) Industries Ltd 生产的吲达帕胺缓释片(1.5mg×1片)的生物等效性;
[Translation] Evaluation of a single postprandial administration of indapamide sustained-release tablets (1.5 mg × 1 tablet) produced by Ningxia Kangya Pharmaceutical Co., Ltd. and commercially available indapamide produced by Servier (Ireland) Industries Ltd in Chinese healthy subjects Bioequivalence of dapamide sustained-release tablets (1.5mg × 1 tablet);
100 Clinical Results associated with Kangya of Ningxia Pharmaceutical Co., Ltd.
0 Patents (Medical) associated with Kangya of Ningxia Pharmaceutical Co., Ltd.
100 Deals associated with Kangya of Ningxia Pharmaceutical Co., Ltd.
100 Translational Medicine associated with Kangya of Ningxia Pharmaceutical Co., Ltd.