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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.- |
First Approval Date01 Jan 1985 |
JKN2306片在轻度肝功能不全、中度肝功能不全和肝功能正常试验参与者中的药代动力学和安全性的I期临床研究
[Translation] Phase I clinical study of pharmacokinetics and safety of JKN2306 tablets in trial participants with mild hepatic impairment, moderate hepatic impairment, and normal hepatic function.
评价JKN2306片在轻、中度肝功能不全试验参与者中的药代动力学特征及其与肝功能正常试验参与者之间的差异,为肝功能不全试验参与者的合理临床用药提供科学依据
[Translation] This study aims to evaluate the pharmacokinetic characteristics of JKN2306 tablets in participants with mild to moderate hepatic impairment and to compare them with those in participants with normal hepatic function, providing a scientific basis for rational clinical use of the drug in participants with hepatic impairment.
一项评估 JKN2306 片对普伐他汀、安非他酮及其代谢产物羟基安非他酮的药代动力学影响的开放、自身对照、固定序列的 I 期临床研究
[Translation] An open-label, self-controlled, fixed-sequence phase I clinical study evaluating the pharmacokinetic effects of JKN2306 tablets on pravastatin, bupropion, and its metabolite hydroxybupropion.
评估多次口服 JKN2306片对单次口服 OATP1B1底物普伐他汀的药代动力学特征影响。
评估多次口服 JKN2306 片对单次口服 CYP2B6 底物安非他酮的药代动力学特征影响。
评估多次口服 JKN2306 片对单次口服安非他酮在体内代谢后生成的主要活性代谢产物羟基安非他酮的药代动力学特征影响。
[Translation] To evaluate the effect of multiple oral administrations of JKN2306 tablets on the pharmacokinetic characteristics of a single oral administration of the OATP1B1 substrate pravastatin.
To evaluate the effect of multiple oral administrations of JKN2306 tablets on the pharmacokinetic characteristics of a single oral administration of the CYP2B6 substrate bupropion.
To evaluate the effect of multiple oral administrations of JKN2306 tablets on the pharmacokinetic characteristics of hydroxybupropion, the major active metabolite produced after a single oral administration of bupropion.
一项评估JKN2502在中国健康试验参与者及在肾功能损害患者中的安全性、耐受性和药代动力学特征的I期临床试验
[Translation] A Phase I clinical trial evaluating the safety, tolerability, and pharmacokinetic characteristics of JKN2502 in healthy participants in China and in patients with renal impairment.
第一部分研究目的:
主要目的:评价JKN2502在中国健康试验参与者中静脉输注给药的安全性和耐受性。
次要目的:1)评价JKN2502在中国健康试验参与者中静脉输注给药的药代动力学特征;2)评价中国健康试验参与者接受JKN2502静脉输注给药后血药浓度对QT/QTc间期的影响。
探索性目的:初步分析JKN2502在血浆、尿液和粪便中的代谢产物。
第二部分研究目的:
主要目的:评估单次静脉输注JKN2502在肾功能正常及不同程度肾功能损害试验参与者中的药代动力学特征;
次要目的:评价静脉输注JKN2502在肾功能正常及轻、中、重度肾功能损害的试验参与者中的安全性和耐受性。
探索性目的:探索JKN2502药代动力学参数与肾功能指标(如eGFR、血肌酐等)之间的相关性。
[Translation] Part I: Study Objectives
Primary Objective: To evaluate the safety and tolerability of JKN2502 administered intravenously in healthy participants in the Chinese trial.
Secondary Objectives: 1) To evaluate the pharmacokinetic characteristics of JKN2502 administered intravenously in healthy participants in the Chinese trial; 2) To evaluate the effect of plasma drug concentration on the QT/QTc interval after intravenous administration of JKN2502 in healthy participants in the Chinese trial.
Exploratory Objective: To preliminarily analyze the metabolites of JKN2502 in plasma, urine, and feces.
Part II: Study Objectives
Primary Objective: To evaluate the pharmacokinetic characteristics of a single intravenous infusion of JKN2502 in participants with normal renal function and varying degrees of renal impairment.
Secondary Objective: To evaluate the safety and tolerability of intravenous infusion of JKN2502 in participants with normal renal function and mild, moderate, and severe renal impairment.
Exploratory Objective: To explore the correlation between pharmacokinetic parameters of JKN2502 and renal function indicators (such as eGFR, serum creatinine, etc.).
100 Clinical Results associated with Shenzhen Haibin Pharmaceutical Co., Ltd.
0 Patents (Medical) associated with Shenzhen Haibin Pharmaceutical Co., Ltd.
100 Deals associated with Shenzhen Haibin Pharmaceutical Co., Ltd.
100 Translational Medicine associated with Shenzhen Haibin Pharmaceutical Co., Ltd.