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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.United States |
First Approval Date10 Apr 2008 |
评价HR1405-01注射液在轻度、中度肝功能不全和正常肝功能试验参与者中单次静脉给药的药代动力学和安全性的I期临床研究
[Translation] A Phase I clinical study evaluating the pharmacokinetics and safety of HR1405-01 injection after a single intravenous administration in participants with mild to moderate hepatic impairment and normal hepatic function.
主要研究目的:
1. 评价HR1405-01注射液在轻度、中度肝功能不全和正常肝功能试验参与者中的药代动力学特征。
次要研究目的:
1. 评价HR1405-01注射液在轻度、中度肝功能不全和正常肝功能试验参与者中的安全性;
2. 评价HR1405-01注射液的代谢产物M8在轻度、中度肝功能不全和正常肝功能试验参与者中的药代动力学特征。
[Translation] Primary Study Objectives:
1. To evaluate the pharmacokinetic characteristics of HR1405-01 injection in participants with mild to moderate hepatic impairment and normal liver function.
Secondary Study Objectives:
1. To evaluate the safety of HR1405-01 injection in participants with mild to moderate hepatic impairment and normal liver function.
2. To evaluate the pharmacokinetic characteristics of the metabolite M8 of HR1405-01 injection in participants with mild to moderate hepatic impairment and normal liver function.
评价 HR1405-01 注射液在轻度、中度、重度肾功能不全和正常肾功能试验参与者中单次静脉给药的药代动力学和安全性的 I 期临床研究
[Translation] A Phase I clinical study evaluating the pharmacokinetics and safety of HR1405-01 injection after a single intravenous administration in participants with mild, moderate, and severe renal impairment and normal renal function.
主要研究目的:
1. 评价HR1405-01注射液在轻度、中度、重度肾功能不全和正常肾功能试验参与者中的药代动力学特征。
次要研究目的:
1. 评价HR1405-01注射液在轻度、中度、重度肾功能不全和正常肾功能试验参与者中安全性;
2. 评价HR1405-01注射液的代谢产物M8在轻度、中度、重度肾功能不全和正常肾功能试验参与者中的药代动力学特征。
[Translation] Primary Study Objectives:
1. To evaluate the pharmacokinetic characteristics of HR1405-01 injection in participants with mild, moderate, and severe renal impairment and those with normal renal function.
Secondary Study Objectives:
1. To evaluate the safety of HR1405-01 injection in participants with mild, moderate, and severe renal impairment and those with normal renal function;
2. To evaluate the pharmacokinetic characteristics of the metabolite M8 of HR1405-01 injection in participants with mild, moderate, and severe renal impairment and those with normal renal function.
/ CompletedNot Applicable [Translation] Bioequivalence study of ivocasei tablets in humans
主要研究目的:
以南京海融制药有限公司生产的依伏卡塞片(规格:2mg)为受试制剂,以持证商为協和キリン株式会社的依伏卡塞片(规格:2mg)为参比制剂,考察两制剂在空腹和餐后状态下单次给药的药代动力学参数及相对生物利用度,评价两制剂是否具有生物等效性。
次要研究目的:
评价受试制剂和参比制剂在健康研究参与者中的安全性。
[Translation] Primary Study Objective:
Using Ivocasert tablets (2 mg) manufactured by Nanjing Hairong Pharmaceutical Co., Ltd. as the test formulation and Ivocasert tablets (2 mg) manufactured by Kyowa Kirin Co., Ltd. as the reference formulation, we investigated the pharmacokinetic parameters and relative bioavailability of the two formulations after single administration in the fasting and fed states, and evaluated their bioequivalence.
Secondary Study Objective:
Evaluate the safety of the test and reference formulations in healthy study participants.
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