[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.