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The bioavailability of Irbesartan (150 mg) developed by Shenzhen Haibin Pharmaceutical Co., Ltd. was compared with that of reference Irbesartan (Aprovel ®,150 mg) produced by Sanofi Clir SNC. The bioequivalence of single dose of test preparation and reference preparation was evaluated in heathy subjects under fasting and fed conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reference formulation | Experimental | Irbesartan tablet (0.15g/tablet) , Manufacturer: Sanofi Clir SNC |
|
| Test formulation | Experimental | Irbesartan tablet (0.15g/tablet) , Manufacturer: Shenzhen Haibin Pharmaceutical Co., Ltd. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tested Irbesartan Tablet | Drug | T |
| |
| Reference Irbesartan Tablet |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Evaluation of Peak Plasma Concentration | 48hours |
| AUC0-t | Evaluation of Area under the plasma concentration versus time curve (AUC)0-t | 484hours |
| AUC0-∞ | Evaluation of Area under the plasma concentration versus time curve | 48hours |
| Measure | Description | Time Frame |
|---|---|---|
| safety | Monitor all the adverse event | 30days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yu Cao | The Affiliated Hosptial of Qingdao University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affiliated Hospital of Qingdao University Phase I Clinical Research Center | Qingdao | Shandong | 266003 | China |
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| Drug |
R |
|