Benova(Tianjin)Innovation Pharmaceutical Research Co., Ltd.

Primary objective To study the pharmacokinetic behavior of a single intravenous injection of vitamin K1 (10 mg, specification: 1 ml: 10 mg, provided by Bonuo (Tianjin) Innovation Pharmaceutical Research Co., Ltd., produced by CENEXI SAS) and oral vitamin K1 injection (20 mg, specification: 1 ml: 10 mg, provided by Bonuo (Tianjin) Innovation Pharmaceutical Research Co., Ltd., produced by CENEXI SAS) in healthy Chinese subjects under fasting conditions, and to evaluate the pharmacokinetics of intravenous and oral vitamin K1 injection and the absolute bioavailability of oral vitamin K1 injection. Secondary objective To study the safety of intravenous vitamin K1 injection and oral vitamin K1 injection in healthy Chinese subjects.

The main purpose of the preliminary test is to examine the pharmacokinetic parameters and intra-individual coefficient of variation of the test preparation and the reference preparation in healthy subjects under the postprandial condition after oral administration of a single dose of the test preparation and the reference preparation, and to verify the rationality of the settings such as the analysis method of drug concentration in plasma, blood collection time, washout period and cholestyramine administration time. The main purpose of the formal test is to examine the absorption rate and degree of the test preparation and the reference preparation under the fasting and postprandial conditions after oral administration of a single dose of the test preparation and the reference preparation in healthy subjects under the fasting/postprandial condition, and to evaluate whether the test preparation and the reference preparation are bioequivalent. Secondary research purpose: to observe the safety of the test preparation and the reference preparation in healthy subjects.