[Translation] Phase I clinical study on the safety, tolerability, pharmacokinetics and food effects of a single dose of SYN045 tablets in healthy adult subjects
主要目的:评价SYN045片在健康受试者中单次口服给药和不同饮食条件下给药的安全性和耐受性。
次要目的:评价SYN045片在健康受试者中单次口服给药和不同饮食条件下给药后的药代动力学特征。
探索性目的:探索SYN045在血浆、尿液和粪便中的代谢物谱。
[Translation] Primary objective: To evaluate the safety and tolerability of SYN045 tablets after single oral administration and administration under different dietary conditions in healthy subjects.
Secondary objective: To evaluate the pharmacokinetic characteristics of SYN045 tablets after single oral administration and administration under different dietary conditions in healthy subjects.
Exploratory objective: To explore the metabolite profiles of SYN045 in plasma, urine and feces.