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The purpose of this clinical study is to evaluate the pharmacokinetics and safety of BR3409 and co-administration of BR3409-1 and BR3409-2 in healthy volunteers Under Fed Conditions
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BR3409 | Experimental |
| |
| BR3409-1 + BR3409-2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BR3409 | Drug | One tablet administered alone |
| |
| BR3409-1 |
| Measure | Description | Time Frame |
|---|---|---|
| AUCÏ„ | Area under the plasma drug concentration-time curve from 0 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 have body mass index (BMI: weight(kg)/the square of {height(m)}) within the range of 18.0 to 30.0 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 56 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 | Gwanakgu | 08779 | South Korea |
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| Drug |
One tablet administered alone |
|
| BR3409-2 | Drug | One tablet administered alone |
|
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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