维生素K1注射液在健康受试者的随机、开放、两制剂、两序列注射给药比较药代动力学研究
[Translation] A randomized, open-label, two-preparation, two-sequence comparative pharmacokinetic study of vitamin K1 injection in healthy subjects
主要目的:通过空腹试验研究,考察中国健康受试者在空腹条件下单次注射受试制剂维生素 K1 注射液(规格:0.5ml:1mg,深圳欣祺医药科技有限公司提供)与参比制剂维生素 K1 注射液(英文名:Vitamin K1 Injection,规格:0.5ml:1mg,International Medication Systems, Ltd 持证)后的体内药代动力学特征,评价两制剂的生物等效性。
次要目的:评价单次注射维生素 K1 注射液受试制剂及参比制剂在中国健康受试者中的安全性。
[Translation] Main purpose: Through a fasting trial study, examine the efficacy of a single injection of the test preparation vitamin K1 injection (specification: 0.5ml: 1mg, provided by Shenzhen Xinqi Pharmaceutical Technology Co., Ltd.) and the reference preparation vitamin in Chinese healthy subjects under fasting conditions. In vivo pharmacokinetic characteristics of K1 injection (English name: Vitamin K1 Injection, specifications: 0.5ml: 1mg, licensed by International Medication Systems, Ltd) to evaluate the bioequivalence of the two preparations.
Secondary purpose: To evaluate the safety of single-injection vitamin K1 injection test and reference preparations in healthy Chinese subjects.
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