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The purpose of this clinical study is to evaluate the pharmacokinetics and safety between single oral administration of BR3006 and co-administration of BR3006A, BR3006B and BR3006C in healthy adult volunteers under fasting conditions
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BR3006 | Experimental |
| |
| BR3006A+BR3006B+BR3006C | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BR3006 | Drug | One tablet administered alone |
| |
| BR3006A |
| Measure | Description | Time Frame |
|---|---|---|
| AUCt | Area under the plasma drug concentration-time curve from 0 to time t | 0-96 hours after administration |
| Cmax | Maximum concentration of drug in plasma | 0-96 hours after administration |
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Inclusion Criteria:
Those who have body mass index (BMI) of 18.0kg/m2 to 30.0kg/m2 at screening visit.
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* from the date of consent to 14 days after the last administration and disagree to provide their sperm or ovum.
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.
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 |
|
| BR3006B | Drug | One tablet administered alone |
|
| BR3006C | 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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