[Translation] A single-center, randomized, open-label, two-dose, two-period, double-crossover, postprandial single-dose bioequivalence study of hydroxyethyl starch 130/0.4 sodium chloride injection in Chinese healthy subjects
主要目的:本试验为生物等效性试验,以Fresenius Kabi Deutschland GmbH生产的羟乙基淀粉130/0.4氯化钠注射液(商品名:Voluven 6%,规格:500ml)为参比制剂,以华夏生生药业(北京)有限公司生产的羟乙基淀粉130/0.4氯化钠注射液(规格:500ml:30g羟乙基淀粉130/0.4与4.5g氯化钠)为受试制剂,通过单中心、随机、开放、两制剂、双周期、双交叉、餐后单次给药设计的临床试验,为评价两种制剂在餐后给药条件下的生物等效性。次要目的:评价中国健康受试者餐后单次给药受试制剂和参比制剂后的安全性。
[Translation] Primary objective: This study is a bioequivalence study, with hydroxyethyl starch 130/0.4 sodium chloride injection (trade name: Voluven 6%, specification: 500ml) produced by Fresenius Kabi Deutschland GmbH as the reference preparation, and hydroxyethyl starch 130/0.4 sodium chloride injection (specification: 500ml: 30g hydroxyethyl starch 130/0.4 and 4.5g sodium chloride) produced by Huaxia Shengsheng Pharmaceutical (Beijing) Co., Ltd. as the test preparation. This clinical trial is designed as a single-center, randomized, open, two-preparation, two-period, double-crossover, and single-dose after meal, to evaluate the bioequivalence of the two preparations under the condition of postprandial administration. Secondary objective: To evaluate the safety of the test preparation and reference preparation after a single postprandial administration in healthy Chinese subjects.