The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510260, China
NCT Number: NCT05273775
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.
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Notify Me18 year–50 year
Male
Interventional
Phase 1
Guangzhou, Guangdong, 510260, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
HRS5091 Tablets once daily
Midazolam Maleate Tablets single dose
Warfarin Sodium Tablets single dose
Omeprazole Enteric Capsules single dose
Vitamin K1 Tablets once daily
Digoxin Tablets single dose
Rosuvastatin Calcium Tablets single dose
Time frame: Days 1-27
Time frame: Days 1-27
Time frame: Days 1-27
Time frame: Days 1-27
Time frame: Days 1-27
Time frame: Days 1-27
Time frame: Days 1-27
Time frame: Up to 56 days
Jiangsu HengRui Medicine Co., Ltd.
Industry
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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