To Evaluate the Safety, Efficacy, and Pharmacokinetic Characteristics of JMKX003142 Administered Randomly, Open-label, Active-controlled Study in Chinese Renal Edema Patients.
JMKX003142 is an arginine vasopressin(AVP)-V2R antagonist which shows a remarkable diuretic effect in healthy volunteers.In this phase 2 study ,we will observe the safety 、efficacy and pharmacokinetic(PK) characteristics about different dose levels of JMKX003142 tablets in renal edema patients. This phase 2 study is designed as a randomly, open-label, active-controlled study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
216
JMKX003142 tablets for experimental groups.Take the JMKX003142 tablets(on empty stomach) once daily for seven days.
Torasemide tablets for active comparator group.Take the torasemide tablets once daily for seven days.
Fudan University Affiliated Zhongshan Hospital
Shanghai, China
RECRUITINGZhejiang Hangyu Pharmaceutical Co., Ltd(subsidiary of Jemincare)
Shanghai, China
NOT_YET_RECRUITINGbody weight
Time frame: 7 days
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