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Drug Highest PhaseApproved |
First Approval Ctry. / Loc.United States |
First Approval Date10 Apr 2008 |
一项在健康参与者中评价丙磺舒片和利福平胶囊对HR1405-01注射液药代动力学特征影响的单中心、开放、固定序列研究
[Translation] A single-center, open-label, fixed-sequence study evaluating the effects of probenecid tablets and rifampicin capsules on the pharmacokinetic characteristics of HR1405-01 injection in healthy participants.
主要研究目的:
1、评价在健康参与者中多次服用丙磺舒片对HR1405-01注射液药代动力学特征的影响;
2、评价在健康参与者中多次服用利福平胶囊对HR1405-01注射液药代动力学特征的影响。
次要研究目的:
1、评估在健康参与者中丙磺舒片和HR1405-01注射液联合用药的安全性和耐受性;
2、评估在健康参与者中利福平胶囊和HR1405-01注射液联合用药的安全性和耐受性。
探索性目的:
1、评价HR1504-01注射液代谢产物M6和M7在多次服用丙磺舒片或利福平胶囊后健康参与者血液中的水平变化;
探索UGT2B7基因多态性对HR1405-01注射液药代动力学特征和DDI效应程度的影响。
[Translation] Primary Objectives:
1. To evaluate the effect of repeated administration of probenecid tablets on the pharmacokinetic characteristics of HR1405-01 injection in healthy participants;
2. To evaluate the effect of repeated administration of rifampicin capsules on the pharmacokinetic characteristics of HR1405-01 injection in healthy participants.
Secondary Objectives:
1. To assess the safety and tolerability of combined administration of probenecid tablets and HR1405-01 injection in healthy participants;
2. To assess the safety and tolerability of combined administration of rifampicin capsules and HR1405-01 injection in healthy participants.
Exploratory Objectives:
1. To evaluate the changes in the levels of metabolites M6 and M7 of HR1504-01 injection in the blood of healthy participants after repeated administration of probenecid tablets or rifampicin capsules;
2. To explore the effect of UGT2B7 gene polymorphism on the pharmacokinetic characteristics and DDI effect of HR1405-01 injection.
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.
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