Drug-Drug Interaction Study of Itraconazole, Rifampicin and Midazolam With SIM0417/Ritonavir in Healthy Participants

Phase 1 Completed 36 enrolled Jiangsu Simcere Pharmaceutical Co., Ltd.

Non-randomizedParallel-groupOpen-labelTreatment

Summary

This is a phase 1, open-label, fixed-sequence, 2-period drug-drug interaction study to evaluate the pharmacokinetic interactions of itraconazole, rifampicin, midazolam, and SIM0417/ritonavir in healthy Chinese subjects.

Timeline

Start: 2022-12-29
Primary completion: 2023-01-26
Completion: 2023-02-14

Publications

Ye PP, Yao BF, Yang Y, Yang XM, Li Q, Song LL, Chen KG, Zhou HY, Shi JY, Zhang YH, Zhao FR, Guo ZJ, Xu SS, Chen J, Goh AH, Zhu SW, Zheng Y, Zhao W. Drug-drug interactions of simnotrelvir/ritonavir: an open-label, fixed-sequence, two-period clinical trial. Clin Microbiol Infect. 2025 Jan;31(1):101-107. doi: 10.1016/j.cmi.2024.09.007. Epub 2024 Sep 18.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Itraconazole	Small molecule	200 mg	—
Subject	Midazolam	Small molecule	2 mg	—
Subject	Rifampin	Small molecule	0.6 g	—
Subject	Ritonavir	Other / unclassified	100 mg	—
Subject	simnotrelvir	Small molecule	750 mg	—

Indications

No indication recorded.