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The purpose of this clinical study is to evaluate the pharmacokinetics and the safety after administration of BR1018 and coadministration of BR1018A and BR1018B in healthy volunteers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BR1018 | Experimental |
| |
| BR1018A+BR1018B | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BR1018 | Drug | One tablet administered alone |
| |
| BR1018A |
| Measure | Description | Time Frame |
|---|---|---|
| AUCt | Area under the plasma drug concentration-time curve from 0 to time t | 0-72 hours after administration |
| Cmax | Maximum concentration of drug in plasma | 0-72 hours after administration |
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Inclusion Criteria:
Those who have body mass index (BMI) of more than 18.0kg/m2 and less than 30.0kg/m2 at screening visit.
Those who sign written consent spontaneously after listening to and understanding sufficient explanation of the purpose and contents of this clinical trial, characteristics of the Investigational products, expected adverse events, etc.
Those who agree to rule out the possibility of their and their spouses' or sexual partners' pregnancy by using methods of contraception accepted in clinical trial*(Except for hormone drugs) from the date of consent to 14 days after the last administration and disagree to provide their sperm or ovum.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Center, H PLUS Yangji Hospital | Seoul | South Korea |
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| Drug |
One tablet administered alone |
|
| BR1018B | Drug | One tablet administered alone |
|
| ID | Term |
|---|---|
| D000075222 | Essential Hypertension |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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