NCT05273775

A Pharmacokinetic Study to Evaluate the Drug Interaction Between HRS5091 and Probe Drugs in Healthy Volunteers

A Single-center, Single-arm, Open-label, Fixed-sequence, Self-controlled Study of the Effects of HRS5091 on the Pharmacokinetics of Midazolam, S-warfarin, Omeprazole, Digoxin and Rosuvastatin in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This is a drug-drug interaction study conducted in healthy volunteers to evaluate the effect of HRS5091 on CYP3A4, CYP2C9, CYP2C19, P-gp, BCRP and OATP1B1, using midazolam, s-warfarin, omeprazole, digoxin and rosuvastatin as probe drugs.

Conditions

• Chronic Hepatitis B

Interventions

Type	Name	Description
DRUG	HRS5091 Tablets	HRS5091 Tablets once daily
DRUG	Midazolam Maleate Tablets	Midazolam Maleate Tablets single dose
DRUG	Warfarin Sodium Tablets	Warfarin Sodium Tablets single dose
DRUG	Omeprazole Enteric Capsules	Omeprazole Enteric Capsules single dose
DRUG	Vitamin K1 Tablets	Vitamin K1 Tablets once daily
DRUG	Digoxin Tablets	Digoxin Tablets single dose
DRUG	Rosuvastatin Calcium Tablets	Rosuvastatin Calcium Tablets single dose

Timeline

• Start date: 2022-04-29
• Primary completion: 2022-06-23
• Completion: 2022-06-23
• First posted: 2022-03-10
• Last updated: 2022-12-23

Locations

1 site across 1 country: China