Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430000, China
NCT Number: NCT05392127
This is a drug-drug interaction study conducted in healthy volunteers to evaluate the pharmacokinetic effect of SHR0302 on CYP3A4, CYP2C9, CYP2C9, CYP2C19, using midazolam, s-warfarin, omeprazole, and repaglinide as probe drugs.
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Notify Me18 year–45 year
Male
Interventional
Phase 1
Wuhan, Hubei, 430000, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
SHR0302 Tablets once daily
Midazolam Maleate Tablets single dose
Warfarin Sodium Tablets single dose
Omeprazole Enteric Capsules single dose
Vitamin K1 Tablets once daily
Repaglinide Tablets single dose
Time frame: Days 1-29
Time frame: Days 1-29
Time frame: Days 1-29
Time frame: Days 1-29
Time frame: Days 1-29
Time frame: Days 1-29
Time frame: Days 1-29
Time frame: Up to 35 days
Jiangsu HengRui Medicine Co., Ltd.
Industry
A Single-center, Open-label, Single-arm, Fixed-sequence Study to Evaluate the Pharmacokinetic Effects of SHR0302 Tablets on Substrates of CYP3A4, CYP2C8, CYP2C9, CYP2C19 in Healthy Volunteers
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
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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