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The purpose of this clinical trial is to evaluate the pharmacokinetics and the safety after administration of "BR1019" and co-administration of "BR1019-3" and "BR1019-2" in healthy volunteers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BR1019 | Experimental |
| |
| BR1019-2 + BR1019-3 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BR1019 | Drug | One tablet administered alone |
| |
| BR1019-2 |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve from time zero to time Ï„ | 0-48 hours after administration | |
| Maximum concentration of drug in plasma | 0-48 hours after administration |
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Inclusion Criteria:
Those have body mass index (BMI) within the range of 18.0 to 30.0kg/m2 at screening visit.
Those who spontaneously decide to participate and sign written consent to comply with the subject's precautions during the clinical trial period after listening to and fully understanding detailed explanation of this clinical trial
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 the first administration of the investigational products to 7 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 |
|
| BR1019-3 | Drug | One tablet administered alone |
|
| ID | Term |
|---|---|
| D000075222 | Essential Hypertension |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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