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MechanismBacterial DNA gyrase inhibitors [+1] |
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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.China |
First Approval Date27 May 2016 |
一项III期、多中心、随机、双盲研究,评价TG-1000对比安慰剂在急性流感病毒感染无并发症的成人和青少年患者中的疗效和安全性
[Translation] A Phase III, multicenter, randomized, double-blind study evaluating the efficacy and safety of TG-1000 versus placebo in adults and adolescents with uncomplicated acute influenza virus infection
主要研究目的
评价TG-1000对比安慰剂在急性流感病毒感染无并发症的成人和青少年受试者的临床疗效。
次要研究目的
1、评价TG-1000对比安慰剂在急性流感病毒感染无并发症的成人和青少年受试者中的抗病毒效果。 2、评价TG-1000对比安慰剂治疗成人和青少年受试者在临床症状转归和流感相关并发症方面的差异。
[Translation] Main study objectives
To evaluate the clinical efficacy of TG-1000 versus placebo in adult and adolescent subjects with acute influenza virus infection without complications.
Secondary study objectives
1. To evaluate the antiviral effect of TG-1000 versus placebo in adult and adolescent subjects with acute influenza virus infection without complications. 2. To evaluate the differences in clinical symptom outcomes and influenza-related complications in adult and adolescent subjects treated with TG-1000 versus placebo.
中国成年男性健康受试者单次口服[14C]TG-1000的体内物质平衡研究
[Translation] Study on the balance of substances in the body after a single oral administration of [14C]TG-1000 in healthy adult male subjects in China
评价中国成年男性健康受试者单剂量口服[14C]TG-1000的体内物质平衡,揭示TG-1000在人体内的药代动力学整体特征,为该药的合理使用提供参考。
[Translation] To evaluate the in vivo material balance of [14C]TG-1000 after a single oral dose of [14C]TG-1000 in healthy adult male subjects in China, reveal the overall pharmacokinetic characteristics of TG-1000 in humans, and provide a reference for the rational use of the drug.
评价口服苹果酸奈诺沙星(Nemonoxacin)治疗成人社区获得性肺炎患者的有效性和安全性的多中心Ⅳ期临床研究
[Translation] A multicenter phase IV clinical study to evaluate the efficacy and safety of oral nemonoxacin malate in the treatment of adult patients with community-acquired pneumonia
评价口服苹果酸奈诺沙星治疗成人社区获得性肺炎的临床和微生物学疗效以及安全性,同时了解成人社区获得性肺炎患者连续口服苹果酸奈诺沙星的群体药代动力学(PPK)特征及评价药代动力学(PK)/药效学(PD)分析结果。
[Translation] To evaluate the clinical and microbiological efficacy and safety of oral nemonoxacin malate in the treatment of community-acquired pneumonia in adults, and to understand the population pharmacokinetic (PPK) characteristics of continuous oral nemonoxacin malate in adult patients with community-acquired pneumonia and evaluate the results of pharmacokinetic (PK)/pharmacodynamic (PD) analysis.
100 Clinical Results associated with Taigen Biopharmaceuticals Co. (Beijing), Ltd.
0 Patents (Medical) associated with Taigen Biopharmaceuticals Co. (Beijing), Ltd.
100 Deals associated with Taigen Biopharmaceuticals Co. (Beijing), Ltd.
100 Translational Medicine associated with Taigen Biopharmaceuticals Co. (Beijing), Ltd.