[Translation] A Phase I clinical trial evaluating the safety, tolerability, pharmacokinetic characteristics, and food effects of a single oral dose of SYH2056 tablets in healthy Chinese subjects.
主要目的:(1)评价健康受试者单次口服SYH2056片的安全性和耐受性以及对神经精神状态的影响; (2)评价健康受试者在空腹条件下单次口服SYH2056片的药代动力学影响;(3)评价食物对SYH2056片在健康受试者体内的药代动力学的影响。
次要目的:(1)初步探索健康受试者在空腹条件下单次服用SYH2056片的代谢转化研究;(2)评价高脂饮食对健康受试者服用SYH2056片的安全性的影响;(3)评价健康受试者单次口服SYH2056片的潜在致幻性和主观药物喜好及早期依赖性信号。
[Translation] Primary objectives: (1) To evaluate the safety and tolerability of a single oral dose of SYH2056 tablets in healthy subjects and its effects on neuropsychiatric status; (2) To evaluate the pharmacokinetic effects of a single oral dose of SYH2056 tablets in healthy subjects under fasting conditions; (3) To evaluate the effects of food on the pharmacokinetics of SYH2056 tablets in healthy subjects.
Secondary objectives: (1) To conduct a preliminary study on the metabolic transformation of a single oral dose of SYH2056 tablets in healthy subjects under fasting conditions; (2) To evaluate the effects of a high-fat diet on the safety of SYH2056 tablets in healthy subjects; (3) To evaluate the potential hallucinogenicity, subjective drug preference, and early dependence signals of a single oral dose of SYH2056 tablets in healthy subjects.