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The objective of this clinical study is to evaluate the pharmacokinetics and the safety after administration of "BR1019" and co-administration of "BR1019-1" and "BR1019-2" in healthy volunteers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence Group A | Experimental | The investigational products will be administered according to the treatment groups assigned to each sequence group in Period 1~4. *Sequence Group A [Period 1, 3] Co-administration of BR1019-1(R1) and BR1019-2(R2). [Period 2, 4] Administration of BR1019(T) |
|
| Sequence Group B | Experimental | The investigational products will be administered according to the treatment groups assigned to each sequence group in Period 1~4. *Sequence Group B [Period 1, 3] Administration of BR1019(T) [Period 2, 4] Co-administration of BR1019-1(R1) and BR1019-2(R2). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BR1019 | Drug | One tablet administered alone |
| |
| Measure | Description | Time Frame |
|---|---|---|
| AUCÏ„ | Area under the concentration-time curve from time zero to time Ï„ | 0-48 hours after administration |
| Cmax | Maximum concentration of drug in plasma | 0-48 hours after administration |
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Inclusion Criteria:
Those who have body mass index (BMI) within the range of 18.0 to 30.0kg/m² at screening visit
Those who decide to voluntarily participate after listening to and understanding the detailed explanation of this clinical trial and who sign a written consent to comply with the subject's precautions during this clinical trial.
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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| BR1019-1 |
| Drug |
One tablet administered alone |
|
| BR1019-2 | Drug | One tablet administered alone |
|
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D000075222 | Essential Hypertension |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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