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In the last four decades, several classes of diuretics have been the first line option for the therapy of widespread hypertension. However, all the classes of diuretics cause alteration of potassium homeostasis. The primary objective of this study is to assess the safety and tolerability of SHR0532 tablets in healthy subjects. In addition, this study will provide information on Pharmacokinetics and Pharmacodynamics of SHR0532 tablets in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR0532 | Experimental | Up to 5 cohorts of healthy subjects will receive a single dose of oral SHR0532 tablet. |
|
| Placebo | Experimental | Up to 5 cohorts of healthy subjects will receive a single dose of oral placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR0532 | Drug | Ascending dose oral adminstration |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with adverse events and serious adverse events | Pre-dose to 5 days after dose administration |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma concentration versus time curve (AUC) of SHR-0532 | Pre-dose to 5 days after dose administration | |
| Maximum observed serum concentration (Cmax) of SHR-0532 | Pre-dose to 5 days after dose administration |
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Inclusion Criteria:
Exclusion Criteria:
12.Pregnant or Serum β-hCG > 5mIU/mL at baseline or women who are breastfeeding; etc.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuanwei Jia, Ph.D. | Contact | +86-15155324471 | jiayuanwei123925@foxmail.com | |
| Jie Shen, Ph.D. | Contact | +86-15155324471 | shenjie-yjs@qq.com |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Drug |
Ascending dose oral administration |
|
| Time to maximum observed serum concentration (tmax) of SHR-0532 | Pre-dose to 5 days after dose administration |
| Time to elimination half-life (t1/2) of SHR-0532 | Pre-dose to 5 days after dose administration |
| Apparent total clearance of the drug from plasma after oral administration (CL/F) of SHR-0532 | Pre-dose to 5 days after dose administration |
| Apparent volume of distribution after non-intravenous administration (V/F) of SHR-0532 | Pre-dose to 5 days after dose administration |
| Renal clearance of the drug from plasma (CLR) of SHR-0532 | Pre-dose to 5 days after dose administration |
| Cumulative amount of unchanged drug excreted into the urine(Ae) of SHR-0532 | Pre-dose to 5 days after dose administration |