氨磺必利注射液用于预防术后恶心呕吐的有效性和安全性的随机、双盲、安慰剂平行对照、多中心Ⅲ期临床试验
[Translation] A randomized, double-blind, placebo-controlled, multicenter phase III clinical trial on the efficacy and safety of amisulpride injection in preventing postoperative nausea and vomiting
主要目的:
评价氨磺必利注射液预防术后恶心和呕吐的有效性,为本品的注册申请提供依据。
次要目的:
1)评价氨磺必利注射液预防术后恶心和呕吐的安全性。
2)评价氨磺必利注射液在中国患者中预防术后恶心和呕吐的药代动力学特征。
[Translation] Primary objective:
To evaluate the effectiveness of amisulpride injection in preventing postoperative nausea and vomiting, and to provide a basis for the registration application of this product.
Secondary objectives:
1) To evaluate the safety of amisulpride injection in preventing postoperative nausea and vomiting.
2) To evaluate the pharmacokinetic characteristics of amisulpride injection in preventing postoperative nausea and vomiting in Chinese patients.
评估受试制剂阿瑞匹坦注射液与参比制剂“CINVANTI®”作用于健康成年受试者的单中心、开放、随机、单剂量、三周期、交叉生物等效性研究
[Translation] A single-center, open-label, randomized, single-dose, three-period, crossover bioequivalence study to evaluate the test formulation aprepitant injection and the reference formulation "CINVANTI®" in healthy adult subjects
主要研究目的
研究单次输注受试制剂阿瑞匹坦注射液(规格:18mL:130mg)与参比制剂阿瑞匹坦注射液(CINVANTI®,规格:18mL:130mg)在健康受试者体内的药代动力学特征,评价两种制剂的生物等效性。
次要研究目的
研究受试制剂阿瑞匹坦注射液18mL:130mg和参比制剂“CINVANTI®”18mL:130mg在健康受试者中的安全性以及评价两种给药方式的生物利用度相关性。
[Translation] Main study objectives
To study the pharmacokinetic characteristics of a single infusion of the test preparation aprepitant injection (specification: 18mL:130mg) and the reference preparation aprepitant injection (CINVANTI®, specification: 18mL:130mg) in healthy subjects and evaluate the bioequivalence of the two preparations.
Secondary study objectives
To study the safety of the test preparation aprepitant injection 18mL:130mg and the reference preparation "CINVANTI®" 18mL:130mg in healthy subjects and to evaluate the bioavailability correlation of the two administration methods.
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