NCT05665647 - Drug-Drug Interaction Study of Itraconazole, Rifampicin and Midazolam With SIM0417/Ritonavir in Healthy Participants | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

December 29, 2022

Primary Completion Date

January 26, 2023

Study Completion Date

February 14, 2023

Conditions

Healthy Volunteers

Interventions

DRUG

Cohort 1: SIM0417/ritonavir and itraconazole

SIM0417/Ritonavir: Dose: 750 mg SIM0417 coadministered with 100 mg ritonavir once: Day1-Day2, Day9-Day10, BID; Day3,Day11(once only in the morning); Itraconazole：Dose: 200mg once；Day6-Day13, QD

DRUG

Cohort 2: SIM0417/ritonavir and rifampicin

SIM0417/Ritonavir:Dose: 750 mg SIM0417 coadministered with 100 mg ritonavir once: Day1,Day11(once only in the morning); Rifampicin：Dose: 0.6g once; Day4-Day12, QD

DRUG

Cohort 3: SIM0417/ritonavir and midazolam

SIM0417/Ritonavir: 750 mg SIM0417 coadministered with 100 mg ritonavir, Day3-Day6, BID; Day7(once only in the morning) Midazolam：Dose: 2mg once; Day1, Day6, QD

Trial Locations (1)

250014

Shandong First Medical University, Jinan