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Inactive Indication- |
Drug Highest PhasePhase 2 |
First Approval Ctry. / Loc.- |
First Approval Date- |
评价硫酸益母草碱片用于血脂异常患者的PK-PD特征及疗效和安全性的随机、双盲、安慰剂对照的Ib期临床试验/扩展试验
[Translation] A randomized, double-blind, placebo-controlled phase Ib clinical trial/extension trial to evaluate the PK-PD profile and efficacy and safety of leonurine sulfate tablets in patients with dyslipidemia
探索试验药(硫酸益母草碱片)用于治疗血脂异常患者的PK-PD特征;
初步探索试验药(硫酸益母草碱片)用于治疗血脂异常患者的疗效和安全性。
[Translation] To explore the PK-PD characteristics of the experimental drug (leonurine sulfate tablets) in the treatment of patients with dyslipidemia;
To initially explore the efficacy and safety of the experimental drug (leonurine sulfate tablets) in the treatment of patients with dyslipidemia.
评估硫酸益母草碱片在健康志愿者中安全性、耐受性、药代动力学和药效学动力学特性试验
[Translation] A trial to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic properties of leonurine sulfate tablets in healthy volunteers
评估健康志愿者连续口服不同剂量硫酸益母草碱片的安全性、耐受性、药代动力学特性,为II期临床试验设计提供依据。 评估健康志愿者连续口服不同剂量硫酸益母草碱片的药效动力学特性,探索硫酸益母草碱片对健康志愿者肠道菌群的影响,为II期临床试验及后期临床试验设计提供依据。
[Translation] To evaluate the safety, tolerability and pharmacokinetic properties of continuous oral administration of different doses of Leonurine sulfate tablets in healthy volunteers, and to provide a basis for the design of phase II clinical trials. To evaluate the pharmacodynamics of healthy volunteers taking different doses of Leonurine sulfate tablets continuously, to explore the effect of Leonurine sulfate tablets on the intestinal flora of healthy volunteers, and to provide the basis for the design of phase II clinical trials and later clinical trials.
随机、两周期、两序列、交叉、单剂量、单一中心,评估食物对硫酸益母草碱片剂药代动力学特性影响试验
[Translation] A randomized, two-cycle, two-sequence, crossover, single-dose, single-center, trial to assess the effect of food on the pharmacokinetics of leonurine sulfate tablets
评估食物对硫酸益母草碱片剂药代动力学特性的影响,为后续临床试验给药方案设计提供依据。
[Translation] To evaluate the effect of food on the pharmacokinetic properties of leonurine sulfate tablets, and to provide a basis for the design of dosing regimens for subsequent clinical trials.
100 Clinical Results associated with Zhuhai Hengqin New Area Zhongzhu Zhengtai Med Mgmt Co., Ltd.
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