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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| low dose group | Experimental | low dose of JMKX003142 tablets,take orally once daily,last for 7 days |
|
| median dose group | Experimental | median dose of JMKX003142 tablets,take orally once daily,last for 7 days |
|
| high dose group | Experimental | high dose of JMKX003142 tablets,take orally once daily,last for 7 days |
|
| active comparator group | Active Comparator | torasemide tablets 20mg,take orally once daily,last for 7 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JMKX003142 tablets | Drug | JMKX003142 tablets for experimental groups.Take the JMKX003142 tablets(on empty stomach) once daily for seven days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| body weight | 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lin Shi | Contact | +8617710157616 | shilin2@jemincare.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Affiliated Zhongshan Hospital | Recruiting | Shanghai | 200102 | China |
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| ID | Term |
|---|---|
| D000077786 | Torsemide |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 |
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| Torasemide tablets | Drug | Torasemide tablets for active comparator group.Take the torasemide tablets once daily for seven days. |
|
| Zhejiang Hangyu Pharmaceutical Co., Ltd(subsidiary of Jemincare) | Not yet recruiting | Shanghai | 200102 | China |
|
| Sulfur Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |