[Translation] A single-center, open-label, multi-cohort phase I clinical trial evaluating drug interactions between GP681 tablets and rosuvastatin calcium tablets, digoxin tablets, itraconazole capsules, and oseltamivir phosphate capsules in healthy subjects Research
主要研究目的
1)在中国健康受试者中评价GP681片对瑞舒伐他汀(队列1)、地高辛(队列2)药代动力学特征的影响;
2)在中国健康受试者中评价多剂量伊曲康唑(队列3)对GP681及其主要代谢产物GP1707D07药代动力学特征的影响;
3)在中国健康受试者中评价GP681与奥司他韦(队列4)联合用药的药代动力学相互作用;
次要研究目的
评价中国健康受试者口服GP681片分别与瑞舒伐他汀钙片、地高辛片、伊曲康唑胶囊、磷酸奥司他韦胶囊联合用药后的安全性。
探索性目的
探索CYP450代谢酶和转运体基因多态性对GP681及其主要代谢产物GP1707D07在健康受试者体内的药代动力学特征和药物相互作用中的影响。
[Translation] Main research purpose
1) To evaluate the effect of GP681 tablets on the pharmacokinetic characteristics of rosuvastatin (cohort 1) and digoxin (cohort 2) in Chinese healthy subjects;
2) To evaluate the effect of multiple doses of itraconazole (cohort 3) on the pharmacokinetic characteristics of GP681 and its main metabolite GP1707D07 in Chinese healthy subjects;
3) To evaluate the pharmacokinetic interaction of GP681 combined with oseltamivir (cohort 4) in Chinese healthy subjects;
Secondary research purpose
To evaluate the safety of Chinese healthy subjects after oral administration of GP681 tablets in combination with rosuvastatin calcium tablets, digoxin tablets, itraconazole capsules and oseltamivir phosphate capsules.
exploratory purpose
To explore the effects of CYP450 metabolic enzymes and transporter gene polymorphisms on the pharmacokinetic characteristics and drug interactions of GP681 and its main metabolite GP1707D07 in healthy subjects.