HRS-9231 Injection
DrugHRS-9231 injection.
NCT Number: NCT07275723
The purpose of this study is to evaluate the efficacy of HRS-9231 for Magnetic Resonance Imaging (MRI) of body regions excluding the Central Nervous System (CNS) in patients undergoing MRI examinations, using the patient's own unenhanced MRI images as a control; to demonstrate that the efficacy of HRS-9231 is not inferior to gadobutrol for lesion visualization in body MRI; to evaluate the safety of HRS-9231 for body MRI; and to explore the population pharmacokinetic characteristics of HRS-9231 in subjects undergoing body MRI examinations.
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Notify Me18 year and older
All sexes
Interventional
Phase 3
Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, Shanghai Municipality, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
HRS-9231 injection.
Gadobutrol injection.
Magnetic Resonance Imaging (MRI).
Time frame: Day 1 after procedure.
Time frame: Day 1 after procedure.
Time frame: Day 1 after procedure.
Time frame: Day 1 after procedure.
Time frame: Day 1 after procedure.
Time frame: Day 1 after procedure.
Time frame: Day 1 after procedure.
Time frame: Day 1 after procedure.
Time frame: Day 1 after procedure.
Time frame: Day 1 after procedure.
Time frame: Day 1 after procedure.
Time frame: Day 1 after procedure.
Time frame: Day 1 after procedure.
Shanghai Shengdi Pharmaceutical Co., Ltd
Industry
A Multicenter, Randomized, Double-Blind, Positive-Controlled, Cross-Over Phase III Clinical Trial Evaluating the Efficacy and Safety of HRS-9231 for Body Parts (Non-Central Nervous System) Magnetic Resonance Imaging (MRI)
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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.