[Translation] A randomized, open-label, two-formulation, two-period, two-sequence, double-crossover, intravenous bioequivalence study of vitamin K1 injection in healthy subjects
主要目的:以海南美康达药业有限公司研制的维生素K1注射液(规格:1mL:10mg)为受试制剂(T),Cheplapharm Arzneimittel GmbH/Roche Pharma AG生产的维生素K1注射液(商品名:Konakion® MM 10mg;规格:1mL:10mg)为参比制剂(R),考察受试制剂和参比制剂在中国健康受试者空腹状态下静脉注射单次给药的药代动力学参数,评价两制剂是否具有生物等效性。
次要目的:评估海南美康达药业有限公司研制的维生素K1注射液的安全性。
[Translation] Primary objective: To investigate the pharmacokinetic parameters of the single intravenous administration of the test and reference preparations in healthy Chinese subjects in the fasting state, using the vitamin K1 injection (specification: 1mL:10mg) developed by Hainan Meikangda Pharmaceutical Co., Ltd. as the test preparation (T) and the vitamin K1 injection (trade name: Konakion® MM 10mg; specification: 1mL:10mg) produced by Cheplapharm Arzneimittel GmbH/Roche Pharma AG as the reference preparation (R) to evaluate whether the two preparations are bioequivalent.
Secondary objective: To evaluate the safety of the vitamin K1 injection developed by Hainan Meikangda Pharmaceutical Co., Ltd.