Nanjing Zeheng Pharmaceutical Technology Development Co. Ltd.

Primary objective: To evaluate the bioequivalence of the test formulation vitamin K1 injection (0.2 ml: 2 mg, licensed by Jiangsu Runheng Pharmaceutical Co., Ltd.) and the reference formulation vitamin K1 injection (0.2 ml: 2 mg, licensed by Cheppapharm Arzneimittel GmbH, trade name: Konakion MM 2 mg®) in healthy participants after intramuscular injection under fasting conditions, using pharmacokinetic parameters as the primary endpoint. Secondary objective: To observe the safety of the test and reference formulation vitamin K1 injections in healthy participants.

Primary objective: To evaluate the bioequivalence of the test formulation vitamin K1 injection (1ml:10mg, licensed by Jiangsu Runheng Pharmaceutical Co., Ltd.) and the reference formulation vitamin K1 injection (1ml:10mg, licensed by Cheppapharm Arzneimittel GmbH, trade name: Konakion MM 10mg®) in healthy participants under fasting/postprandial and intravenous administration methods, using pharmacokinetic parameters as the primary endpoint. Secondary objective: To observe the safety of the test and reference formulation vitamin K1 injections in healthy participants.

Primary objective: To compare the pharmacokinetic parameters as the primary endpoints in healthy subjects after oral administration of the test preparation sodium valproate sustained-release tablets (I) (Specification: 0.5 g (calculated as sodium valproate), licensee: Nanjing Zeheng Pharmaceutical Technology Development Co., Ltd.) and the reference preparation sodium valproate sustained-release tablets (Specification: 500 mg (calculated as sodium valproate), licensee: SANOFI-AVENTIS FRANCE, trade name: Depakine Chrono®) in fasting/postprandial state, and to evaluate the bioequivalence of the two preparations. Secondary objective: To observe the safety of the test preparation sodium valproate sustained-release tablets (I) and the reference preparation sodium valproate sustained-release tablets in healthy subjects.