A Study to Evaluate the Drug-drug Interactions (DDIs) of GP681 With Rosuvastatin, Digoxin, Itraconazole, Oseltamivir in Chinese Healthy Volunteers

Phase 1 Completed 54 enrolled Jiangxi Qingfeng Pharmaceutical Co. Ltd.

Non-randomizedParallel-groupOpen-labelTreatment

Summary

This study is a four-part, single-center, Open label phase I clinical study to characterize the DDIs potential of GP681 With Rosuvastatin, Digoxin, Itraconazole or Oseltamivir in Chinese healthy volunteers. This study also aims to evaluate the safety and tolerability of GP681 in the presence of Rosuvastatin, Digoxin, Itraconazole, or Oseltamivir.

Timeline

Start: 2023-02-15
Primary completion: 2023-09-11
Completion: 2023-10-31

Publications

Han M, Cui G, Zhao Y, Zuo X, Wang X, Zhang X, Mi N, Jin J, Xiao C, Wang J, Wu W, Li Y, Li J. Evaluation of drug-drug interaction between Suraxavir Marboxil (GP681) and itraconazole, and assessment of the impact of gene polymorphism. Front Pharmacol. 2025 Apr 11;15:1505557. doi: 10.3389/fphar.2024.1505557. eCollection 2024.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Digoxin	Other / unclassified	0.25 mg	Oral
Subject	GP681	Unknown	20 mg	Oral
Subject	GP681	Unknown	40 mg	Oral
Subject	Itraconazole	Small molecule	200 mg	Oral
Subject	Oseltamivir	Small molecule	75 mg	Oral
Subject	Rosuvastatin	Small molecule	10 mg	Oral

Indications

No indication recorded.