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The purpose of this study is to evaluate pharmacokinetic interactions (Drug-Drug interaction) and safety between "BR1015-1" and "BR1015-2" in healthy volunteers.
*Study Objective: After repeated administration of BR1015-1 and BR1015-2 for healthy volunteers, the pharmacokinetic interactions and safety are evaluated.
*Investigational Product (and regimen)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence BR1015-1/BR1015-2/BR1015-1 + BR1015-2 | Experimental | A total of 32 subjects will be enrolled in one sequence group. The investigational products (IPs) will be administered according to the treatment groups(BR1015-1, BR1015-2, BR1015-1 + BR1015-2) assigned to one sequence group in Period 1, Period 2, and Period 3.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BR1015-1 | Drug | - Administration to the BR1015-1 group: 60 mg of BR1015-1 will be administered one tablet once a day, five-day repeated doses. |
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| Measure | Description | Time Frame |
|---|---|---|
| [Part A] Cmax,ss of BR1015-1 | Pharmacokinetic variables - Maximum (peak) plasma concentration of BR1015-1 at steady state (Cmax,ss). | 0~24 hour after administration at Day 5. |
| [Part B] Cmax,ss of BR1015-2 | Pharmacokinetic variables - Maximum (peak) plasma concentration of BR1015-2 at steady state (Cmax,ss). | 0~24 hour after administration at Day 5. |
| [Part A] AUCtau of BR1015-1 | Pharmacokinetic variables - Area under the plasma drug concentration-time curve to the end of the dosing period in multiple dosing of BR1015-1 at steady state. (AUCtau,ss) | 0~24 hour after administration at Day 5. |
| [Part B] AUCtau of BR1015-2 | Pharmacokinetic variables - Area under the plasma drug concentration-time curve to the end of the dosing period in multiple dosing of BR1015-2 at steady state. (AUCtau,ss) | 0~24 hour after administration at Day 5. |
| Measure | Description | Time Frame |
|---|---|---|
| [Part A] AUClast of BR1015-1 | Area under the plasma drug concentration-time curve over the time interval from 0 to the last quantifiable plasma concentration (AUClast) of BR1015-1 | 0~48 hour after administration |
| [Part B] AUClast of BR1015-2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| An-Hye Kim, M.D. Ph.D | CHA University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHA Bundang Medical Center, CHA University | Gyeonggi-do | Seongnam-si | 13520 | South Korea |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C558933 | fimasartan |
| D007190 | Indapamide |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 |
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One-sequence, 3-period study.
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| BR1015-2 | Drug | - Administration to the BR1015-2 group: 1.5 mg of BR1015-2 will be administered one tablet once a day, five-day repeated doses. |
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| BR1015-1 + BR1015-2 | Drug | - Co-administration to the BR1015-1+BR1015-2 group: 60 mg of BR1015-1 one tablet and 1.5 mg of BR1015-2 one tablet will be co-administered once a day, five-day repeated doses. |
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Area under the plasma drug concentration-time curve over the time interval from 0 to the last quantifiable plasma concentration (AUClast) of BR1015-2
| 0~48 hour after administration |
| [Part A] AUCinf of BR1015-1 | Area under the plasma drug concentration-time curve over the time interval from 0 extrapolated to infinity of BR1015-1 | 0~48 hour after administration |
| [Part B] AUCinf of BR1015-2 | Area under the plasma drug concentration-time curve over the time interval from 0 extrapolated to infinity of BR1015-2 | 0~48 hour after administration |
| [Part A] Tmax of BR1015-1 | Time to reach maximum (peak) plasma concentration following drug administration at steady state (Tmax,ss) | 0~24 hour after administration |
| [Part B] Tmax of BR1015-2 | Time to reach maximum (peak) plasma concentration following drug administration at steady state (Tmax,ss) | 0~24 hour after administration |
| [Part A] t1/2 of BR1015-1 | Terminal half-life of BR1015-1 | 0~48 hour after administration |
| [Part B] t1/2 of BR1015-2 | Terminal half-life of BR1015-2 | 0~48 hour after administration |
| Sulfur Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |