[Translation] A Phase I clinical study to evaluate the safety, tolerability, pharmacokinetics and food effects of a single oral dose of VV119 capsules in healthy Chinese adult subjects
主要目的:评估健康受试者单次口服VV119胶囊后的安全性和耐受性;评估健康受试者单次口服VV119胶囊后原形药物及其主要代谢产物的药代动力学(PK)特征;评估高脂餐和标准餐饮食对健康受试者口服VV119胶囊后的PK影响。
次要目的:鉴定健康受试者单次口服VV119胶囊后的代谢产物结构。
[Translation] Primary objective: To evaluate the safety and tolerability of VV119 capsules after a single oral administration in healthy subjects; To evaluate the pharmacokinetic (PK) characteristics of the parent drug and its main metabolites after a single oral administration of VV119 capsules in healthy subjects; To evaluate the effects of high-fat meals and standard meals on the PK of VV119 capsules after oral administration in healthy subjects.
Secondary objective: To identify the structure of metabolites after a single oral administration of VV119 capsules in healthy subjects.