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The purpose of this clinical trial is to evaluate the pharmacokinetics and the safety after administration of BR1015 and co-administration of BR1015-1 and BR1015-2 in healthy volunteers under fasting conditions
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BR1015 | Experimental |
| |
| BR1015-1 + BR1015-2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BR1015 | Drug | One tablet administered alone |
| |
| BR1015-1 |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve from time zero to time Ï„ | 0-72 hours after administration | |
| Maximum concentration of drug in plasma | 0-72 hours after administration |
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Inclusion Criteria:
Those weigh 50 kg or more and have body mass index (BMI) within the range of 18.0 to 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 disagrees 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 | Gwanakgu | 08779 | South Korea |
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| Drug |
One tablet administered alone |
|
| BR1015-2 | Drug | One tablet administered alone |
|
| ID | Term |
|---|---|
| D000075222 | Essential Hypertension |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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