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The purpose of this study is to evaluate the Pharmacokinetics and safety of Azilsartan Trimethylethanolamine in healthy volunteers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1.Azilsartan Trimethylethanolamine | Experimental | Single dose of Azilsartan Trimethylethanolamine with 8.75mg,orally |
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| 2.Azilsartan Trimethylethanolamine | Experimental | Single dose of Azilsartan Trimethylethanolamine with 17.5mg,orally |
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| 3.Azilsartan Trimethylethanolamine | Experimental | Single dose of Azilsartan Trimethylethanolamine with 35mg,orally |
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| 4.Azilsartan Trimethylethanolamine | Experimental | Single dose of Azilsartan Trimethylethanolamine with 70mg,orally |
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| 5.Azilsartan Trimethylethanolamine | Experimental | Single dose of Azilsartan Trimethylethanolamine with 140mg,orally |
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| 6.Azilsartan Trimethylethanolamine |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azilsartan Trimethylethanolamine | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| To study the Pharmacokinetics of Azilsartan Trimethylethanolamine by assessment of drug concentration through blood sample analysis | Pre-dose to 72 hours post-dosee | |
| Number of participants with adverse reactions | The trial shoud be terminated ，if more than a third of participants had grade 2 or more than 2 adverse reactions based on Common Terminology Criteria for Adverse Events(CTCAE) Version 4.02 | Pre-dose to 72 hours post-dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jie Hou, Associate Chief Physician | Contact | 86-022-65209939 |
| Name | Affiliation | Role |
|---|---|---|
| Jie Hou, Associate Chief Physician | TEDA International Cardiovascular Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TEDA International Cardiovascular Hospital | Recruiting | Tianjin | China |
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Single dose of Azilsartan Trimethylethanolamine with 210mg,orally |
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| 7.Azilsartan Trimethylethanolamine | Experimental | Single dose of Azilsartan Trimethylethanolamine with 280mg,orally |
|
| Placebo | Placebo Comparator | Placebo-matching tablets, orally |
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| Placebo | Drug |
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