Burning Point (Nanjing) Biopharmaceutical Technology Co., Ltd

The main purpose of the study is to study the pharmacokinetics of the test preparation vitamin K1 injection (specification: 1ml:10mg) and the reference preparation vitamin K1 injection (specification: 1ml:10mg) in healthy subjects and evaluate the bioequivalence of the two preparations for intravenous injection. The secondary purpose of the study is to observe the safety of the test preparation vitamin K1 injection (1ml:10mg) and the reference preparation vitamin K1 injection (1ml:10mg) in healthy adult subjects.

The main purpose of the study: To study the pharmacokinetics of the test preparation vitamin K1 injection (specification: 1ml:10mg) and the reference preparation vitamin K1 injection (specification: 1ml:10mg) in healthy subjects in the fasting and postprandial state, and to evaluate the bioequivalence of the two preparations in the fasting and postprandial state. Secondary purpose of the study: To observe the safety of the test preparation vitamin K1 injection (1ml:10mg) and the reference preparation vitamin K1 injection (1ml:10mg) in healthy adult subjects.

The bioequivalence of the test preparation, sodium valproate extended-release tablets (I) [Specification: 0.5 g, licensee: Randian (Nanjing) Biopharmaceutical Technology Co., Ltd.] and the reference preparation, sodium valproate extended-release tablets (I) (Depakin®, specification: 0.5 g), licensee: Sanofi (Hangzhou) Pharmaceutical Co., Ltd., was evaluated in healthy male and female subjects under fasting/postprandial conditions.