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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.United States |
First Approval Date10 Apr 2008 |
评估HR1405-01 注射液在治疗骨科手术后中到重度疼痛的有效性和安全性的多中心、随机、双盲、阳性药及安慰剂平行对照的Ⅲ期临床研究
[Translation] A multicenter, randomized, double-blind, active-drug and placebo-controlled phase III clinical trial evaluating the efficacy and safety of HR1405-01 injection in treating moderate to severe pain after orthopedic surgery.
主要目的: 评价HR1405-01 注射液治疗骨科手术后中到重度疼痛受试者的有效性。次要目的: 评价HR1405-01 注射液治疗骨科手术后中到重度疼痛受试者的安全性。 评价HR1405-01 注射液治疗骨科手术后中到重度疼痛受试者的药代动力学特征。
[Translation] Primary objective: To evaluate the efficacy of HR1405-01 injection in treating moderate to severe pain after orthopedic surgery. Secondary objectives: To evaluate the safety of HR1405-01 injection in treating moderate to severe pain after orthopedic surgery. To evaluate the pharmacokinetic characteristics of HR1405-01 injection in treating moderate to severe pain after orthopedic surgery.
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.
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