Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this clinical trial is to evaluate the pharmacokinetics and the safety after administration of BR1015-A and co-administration of BR1015-3 and BR1015-2 in healthy volunteers under fasting conditions
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BR1015-A | Experimental |
| |
| BR1015-3+BR1015-2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BR1015-A | Drug | One tablet administered alone |
| |
| BR1015-3 |
| Measure | Description | Time Frame |
|---|---|---|
| AUCt of Fimasartan | Area under the Plasma Concentration-Time Curve from Time Zero to Time t of Fimasartan | From pre-dose (0 hour) through 48 hours post-dose in each period (Periods 1-4). |
| AUCt of Indapamide | Area under the Plasma Concentration-Time Curve from Time Zero to Time t of Indapamide | From pre-dose (0 hour) through 72 hours post-dose in each period (Periods 1-2). |
| Cmax of Fimasartan | Maximum Concentration of Drug in Plasma of Fimasartan | From pre-dose (0 hour) through 48 hours post-dose in each period (Periods 1-4). |
| Cmax of Indapamide | Maximum Concentration of Drug in Plasma of Indapamide | From pre-dose (0 hour) through 72 hours post-dose in each period (Periods 1-2). |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Soo Hee Kim | Contact | 02-708-8000 | shkim0127@boryung.co.kr |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
One tablet administered alone |
|
| BR1015-2 | Drug | One tablet administered alone |
|
| ID | Term |
|---|---|
| D000075222 | Essential Hypertension |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided