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| Name | Class |
|---|---|
| Shandong Huizhi Pharmaceutical Technology Co., Ltd. | UNKNOWN |
| Cancer Institute and Hospital, Chinese Academy of Medical Sciences | OTHER |
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Salvianolic acid A has a variety of pharmacological effects, such as: anti-oxidation, scavenging oxygen free radicals, anti-fibrosis, anti-myocardial ischemia, anti-coagulation, anti-thrombosis, anti-tumor, etc. Professor Du Guanhua, at Institue of Materia Medica, Chinese Academy of Medical Sciences, first discovered that salvianolic acid A can alleviate diabetic complications and improve patients' quality of life. With the support of major national science and technology projects, the preclinical research work of salvianolic acid A was completed, and the application was approved by the State Food and Drug Administration (Clinical Approval No.: 2016L06293). Peking University First Hospital was used as the research unit. This study is the first human clinical trial of the drug. The project leader of this study is Professor Cui Yimin from Peking University First Hospital. The sponsor of this project is Shandong Huizhi Pharmaceutical Technology Co., Ltd.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental |
| |
| Placebo | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Salvianolic Acid A | Drug | 4 anticipated doses are 30 mg, 90 mg, 180 mg and 270 mg, respectively. All of these are single-dose study. |
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| Measure | Description | Time Frame |
|---|---|---|
| Subject incidence of treatment-emergent adverse events | 7 days | |
| Percentage of participants with change from baseline in vital signs | Heart rate, Blood Pressure,auxillary temperature | 7 days |
| Change from baseline in electrocardiograms (ECGs) | PR interval, QT interval, QTc interval, QTcF, and rhythm abnormalities | 7 days |
| Percentage of participants with change from baseline in clinical laboratory parameters | blood routine, urine routine, biochemical parameters of blood and urine,coagulation tests | 7 days |
| PK profile of Salvianolic acid A following administration of multiple doses assessed by area under the curve [AUC] | 2 days | |
| PK profile of Salvianolic acid A following administration of multiple doses assessed by maximum observed concentration [Cmax] | 2 days | |
| PK profile of Salvianolic acid A following administration of multiple doses assessed by time of occurrence of Cmax [tmax] | 2 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaocong Pang, Ph.D. | Contact | 010-66110802 | pangxiaocong1227@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Pharmacy, Base for Clinical Trial, Peking University First Hospital | Recruiting | Beijing | Beijing Municipality | 100034 | China |
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| ID | Term |
|---|---|
| C066201 | salvianolic acid A |
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| Placebo Oral Tablet | Drug | Placebo tablets containing no salvianolic acid A will be given to healthy subjects. |
|