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Drug Highest PhaseApproved |
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First Approval Date23 Jul 2021 |
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Drug Highest PhasePhase 2 |
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/ RecruitingNot Applicable 杏香兔耳风胶囊治疗急性咽炎(肺胃热盛证)的随机、双盲、安慰剂平行对照、多中心临床验证试验
[Translation] A randomized, double-blind, placebo-controlled, multicenter clinical validation trial of Xingxiang Tuerfeng Capsule in the treatment of acute pharyngitis (lung and stomach heat syndrome)
本研究在临床前研究的基础上,以“第3天咽痛VAS评分较基线的变化”为主要疗效指标,采用随机、双盲、安慰剂对照、多中心临床验证试验设计,评价杏香兔耳风胶囊治疗急性咽炎(肺胃热盛证)的有效性和安全性,对前期临床研究结果加以补充,并为其增加“治疗急性咽炎”的适应症提供依据。
[Translation] Based on preclinical studies, this study used "change in throat pain VAS score compared with baseline on the 3rd day" as the main efficacy indicator, and adopted a randomized, double-blind, placebo-controlled, multicenter clinical verification trial design to evaluate the efficacy and safety of Xingxiang Tuerfeng Capsule in the treatment of acute pharyngitis (lung and stomach heat syndrome), to supplement the results of previous clinical studies, and to provide a basis for adding the indication of "treatment of acute pharyngitis".
延藜胶囊治疗功能性勃起功能障碍(肾阳虚证)随机、双盲、安慰剂平行对照、多中心Ⅱ期临床试验
[Translation] A randomized, double-blind, placebo-controlled, multicenter phase II clinical trial of Yanli Capsule in the treatment of functional erectile dysfunction (kidney yang deficiency syndrome)
初步评价延藜胶囊治疗功能性勃起功能障碍(肾阳虚证)有效性与安全性。
[Translation] To preliminarily evaluate the efficacy and safety of Yanli Capsule in the treatment of functional erectile dysfunction (kidney yang deficiency syndrome).
/ Not yet recruitingPhase 1 [Translation] Pharmacokinetics of Ozagrel Hydrochloride Tablets in Humans
本试验的目的是在健康志愿受试者中研究通辽市华邦药业有限公司提供的盐酸奥扎格雷片,完成单次、多次给药药动学试验,通过建立血样中奥扎格雷及其代谢物的方法学和检测血浆样本,得到相应的药动学参数,了解盐酸奥扎格雷片在人体内动态变化的规律,多次连续给药体内蓄积情况,为临床合理用药提供依据。
[Translation] The purpose of this study is to study the single-dose and multiple-dose pharmacokinetic studies of Ozagrel Hydrochloride Tablets provided by Tongliao Huabang Pharmaceutical Co., Ltd. in healthy volunteers. By establishing the methodology of Ozagrel and its metabolites in blood samples and detecting plasma samples, the corresponding pharmacokinetic parameters are obtained to understand the dynamic changes of Ozagrel Hydrochloride Tablets in the human body and the accumulation in the body after multiple continuous administrations, so as to provide a basis for rational clinical drug use.
100 Clinical Results associated with Jiangxi Yintao Pharmaceutical Co., Ltd.
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100 Translational Medicine associated with Jiangxi Yintao Pharmaceutical Co., Ltd.