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Drug Highest PhaseApproved |
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First Approval Date14 Sep 2022 |
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Drug Highest PhasePhase 2 |
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健康受试者口服广金钱草总黄酮胶囊的药物代谢转化和药代动力学研究
[Translation] Study on drug metabolism, transformation and pharmacokinetics of total flavonoids capsules of Lysimachia sibiricum in healthy subjects after oral administration
主要研究目的 鉴定广金钱草总黄酮胶囊在体内的主要成分及代谢物,明确血浆中的主要吸收成分和主要代谢产物。 次要研究目的 测试广金钱草总黄酮胶囊在人体内的药代动力学参数; 给出血药浓度半定量测试方法与结果; 观察广金钱草总黄酮胶囊多次口服给药在健康受试者中的安全性。
[Translation] The main purpose of the study is to identify the main components and metabolites of Herba Lysimachiae Total Flavonoids Capsules in the body, and to clarify the main absorbed components and main metabolites in plasma. The secondary purpose of the study is to test the pharmacokinetic parameters of Herba Lysimachiae Total Flavonoids Capsules in humans; to provide a semi-quantitative test method and results for blood drug concentration; to observe the safety of Herba Lysimachiae Total Flavonoids Capsules after multiple oral administration in healthy subjects.
广金钱草总黄酮胶囊治疗输尿管结石的随机、双盲、安慰剂平行对照、多中心Ⅲ期临床试验
[Translation] A randomized, double-blind, placebo-controlled, multicenter phase III clinical trial of total flavonoids capsules of Lysimachia sibiricum in the treatment of ureteral calculi
进一步验证广金钱草总黄酮胶囊治疗输尿管结石的有效性和安全性,评价利益与风险关系,为药物注册申请提供充分的依据。
[Translation] Further verify the effectiveness and safety of total flavonoids capsules from Desmodium sibiricum in the treatment of ureteral stones, evaluate the benefit-risk relationship, and provide sufficient basis for drug registration applications.
广金钱草总黄酮胶囊治疗输尿管结石的随机、双盲、安慰剂平行对照、多中心Ⅲ期临床试验
[Translation] A randomized, double-blind, placebo-controlled, multicenter phase III clinical trial of total flavonoids capsules of Lysimachia sibiricum in the treatment of ureteral calculi
进一步验证广金钱草总黄酮胶囊治疗输尿管结石的有效性和安全性,评价利益与风险关系,为药物注册申请提供充分的依据。
[Translation] Further verify the effectiveness and safety of total flavonoids capsules from Desmodium sibiricum in the treatment of ureteral stones, evaluate the benefit-risk relationship, and provide sufficient basis for drug registration applications.
100 Clinical Results associated with Beijing Haitai United Pharmaceutical Technology Development Co., Ltd.
0 Patents (Medical) associated with Beijing Haitai United Pharmaceutical Technology Development Co., Ltd.
100 Deals associated with Beijing Haitai United Pharmaceutical Technology Development Co., Ltd.
100 Translational Medicine associated with Beijing Haitai United Pharmaceutical Technology Development Co., Ltd.