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MechanismGABAA receptor positive allosteric modulators |
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Inactive Indication- |
Drug Highest PhasePhase 3 |
First Approval Ctry. / Loc.- |
First Approval Date- |
一项评价注射用甲氧依托咪酯盐酸盐用于择期手术患者全身麻醉诱导的有效性和安全性的多中心、随机、双盲、依托咪酯平行对照的 III 期临床研究
[Translation] A multicenter, randomized, double-blind, etomidate parallel-controlled Phase III clinical study to evaluate the efficacy and safety of injectable etomidate hydrochloride for the induction of general anesthesia in patients undergoing elective surgery.
主要研究目的:评价 ET-26 与依托咪酯相比,在择期手术受试者全身麻醉诱导中的有效性。
次要研究目的:评价 ET-26 与依托咪酯相比,在择期手术受试者全身麻醉诱导中的安全性。
探索性研究目的:评估 ET-26/依托咪酯、依托咪酯酸的药代动力学(PK)特征。建立群体药代动力学模型,评估药代/药效关系。评估 CYP2C19 基因多态性对 ET-26 药代/药效的影响;评估 BIS 原始脑电图中癫痫样波的发生情况。
[Translation] Primary study objective: To evaluate the effectiveness of ET-26 compared with etomidate in the induction of general anesthesia in subjects undergoing elective surgery.
Secondary study objective: To evaluate the safety of ET-26 compared with etomidate in the induction of general anesthesia in subjects undergoing elective surgery.
Exploratory study purpose: To evaluate the pharmacokinetic (PK) characteristics of ET-26/etomidate and etomidate acid. Establish a population pharmacokinetic model to evaluate pharmacokinetic/pharmacodynamic relationships. To assess the impact of CYP2C19 gene polymorphisms on the pharmacokinetics/efficacy of ET-26; to assess the occurrence of epileptiform waves in BIS raw electroencephalograms.
[14C]ET-26 在中国健康受试者中的物质平衡研究
[Translation] [14C]ET-26 Material Balance Study in Chinese Healthy Subjects
主要研究目的:
1) 定量分析受试者单次静脉推注[14C]ET-26 后排泄物中的总放射性,获得人体放射性排泄率数据和主要排泄途径;
2) 定量分析受试者单次静脉推注[14C]ET-26 后静脉全血和血浆中的总放射性,获得静脉血浆总放射性的药代动力学参数,并考察静脉全血和血浆中总放射性的分配情况;
3) 定量分析受试者单次静脉推注[14C]ET-26 后人静脉血浆、尿液和粪便的放射性代谢物谱,鉴定主要代谢产物,确定 ET-26 在人体内的代谢途径及消除途径。
次要研究目的:
1) 采用已验证的 LC-MS/MS 方法定量分析动/静脉血血浆中 ET-26 和代谢产物 ETA(依托咪酯酸)或其他代谢产物(如适用)的浓度,获得动/静脉血血浆中 ET-26 及其代谢产物 ETA 和其他代谢产物(如适用)的药代动力学参数;
2) 观察受试者单次静注[14C]ET-26 后的安全性。
[Translation] Main research purposes:
1) Quantitatively analyze the total radioactivity in the excreta of subjects after a single intravenous injection of [14C]ET-26, and obtain the data of human radioactive excretion rate and the main excretion route;
2) Quantitatively analyze the total radioactivity in venous whole blood and plasma after a single intravenous injection of [14C]ET-26, obtain the pharmacokinetic parameters of total venous plasma radioactivity, and investigate the total radioactivity in venous whole blood and plasma. distribution of radioactivity;
3) Quantitatively analyze the radioactive metabolite profile of human venous plasma, urine and feces after a single intravenous injection of [14C]ET-26, identify the main metabolites, and determine the metabolic pathway and elimination of ET-26 in the human body way.
Secondary research purposes:
1) Quantitatively analyze the concentrations of ET-26 and the metabolite ETA (etomidate acid) or other metabolites (if applicable) in arterial/venous blood plasma using a validated LC-MS/MS method to obtain arterial/venous blood plasma Pharmacokinetic parameters of ET-26 and its metabolite ETA and other metabolites (if applicable);
2) To observe the safety of subjects after a single intravenous injection of [14C]ET-26.
一项评价注射用甲氧依托咪酯盐酸盐用于择期手术患者全身麻醉诱导有效性和安全性的随机、单盲、依托咪酯平行对照的多中心Ⅱ期临床研究
[Translation] A randomized, single-blind, etomidate parallel-controlled, multicenter phase II clinical study evaluating the efficacy and safety of methetomidate hydrochloride for injection in the induction of general anesthesia in patients undergoing elective surgery
Ⅱa 期: 主要研究目的 确定联合用药下的 ET-26 在择期手术受试者全身麻醉诱导时的临床推荐剂量。 次要研究目的 评价 ET-26 在择期手术受试者全身麻醉诱导中的安全性(包括循环稳定性、 呼吸抑制率、不良事件等)和有效性(包括意识消失的过程情况等)。 探索性目的 评估 ET-26/依托咪酯、依托咪酯酸的药代动力学(PK)特征,评估 ET-26、依托咪酯对肾上腺皮质功能的影响。
Ⅱb 期: 主要研究目的 评价临床推荐剂量的 ET-26 与临床推荐剂量的依托咪酯注射液(简称依托 咪酯)相比,在择期手术患者全身麻醉诱导中的有效性。 次要研究目的 评价 ET-26 与依托咪酯相比在择期手术患者全身麻醉诱导中的安全性(包 括循环稳定性、呼吸抑制率、肌阵挛、不良事件等)及对血清皮质醇的影响。 探索性目的 评估 ET-26/依托咪酯、依托咪酯酸的药代动力学(PK)特征。
[Translation] Phase IIa: Primary study objective To determine the clinically recommended dose of ET-26 in combination therapy for induction of general anesthesia in subjects undergoing elective surgery. Secondary research objectives To evaluate the safety (including circulatory stability, respiratory depression rate, adverse events, etc.) and efficacy (including the process of loss of consciousness, etc.) of ET-26 in the induction of general anesthesia in elective surgery subjects. Exploratory purpose To evaluate the pharmacokinetic (PK) characteristics of ET-26/etomidate and etomidate acid, and to evaluate the effect of ET-26 and etomidate on adrenal cortical function.
Phase IIb: Main study objective To evaluate the efficacy of clinically recommended doses of ET-26 compared with clinically recommended doses of etomidate injection (referred to as etomidate) in induction of general anesthesia in patients undergoing elective surgery. Secondary study objective To evaluate the safety of ET-26 compared with etomidate in induction of general anesthesia in patients undergoing elective surgery (including circulatory stability, respiratory depression rate, myoclonus, adverse events, etc.) and its effect on serum cortisol . Exploratory Objectives To evaluate the pharmacokinetic (PK) characteristics of ET-26/etomidate, etomidate acid.
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