[Translation] Randomized, open-label, two-dose, two-sequence oral administration bioequivalence study of vitamin K1 injection in healthy subjects
主要目的:以海南华屹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单次口服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:评估海南华屹药业有限公司研制的维生素K1注射液的安全性。
[Translation] Main purpose: Taking vitamin K1 injection (specification: 1mL: 10mg) developed by Hainan Huayi Pharmaceutical Co., Ltd. as the test preparation (T), vitamin K1 injection (trade name: Konakion ® MM 10mg; specification: 1mL:10mg) is the reference preparation (R), investigate the pharmacokinetic parameters of the test preparation and the reference preparation in Chinese healthy subjects after single oral administration, and evaluate whether the two preparations have biological equivalence.
Secondary objective: To evaluate the safety of vitamin K1 injection developed by Hainan Huayi Pharmaceutical Co., Ltd.