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The objective of this clinical study is to compare the pharmacokinetics and the safety between a fixed-dose combination administration of "BR3005" and co-administration of "BR3005-1" and "BR3005-2" under fed conditions in healthy adult volunteers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BR3005 | Experimental |
| |
| BR3005-1+BR3005-2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BR3005 | Drug | One tablet administered alone, Once a day |
| |
| BR3005-1 |
| Measure | Description | Time Frame |
|---|---|---|
| AUCÏ„ | Area under the Plasma Concentration-Time Curve During a Dosing Interval (tau) | 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 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 | Gwanakgu | 08779 | South Korea |
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| Drug |
One tablet administered alone, Once a day |
|
| BR3005-2 | Drug | One tablet administered alone, Once a day |
|