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An Open-Label, Randomized, Single-Dose Crossover Study to Compare the Pharmacokinetics, Safety and Tolerability Between Fixed-Dose Combination of HCP1904 and Co-Administration of RLD2001-2 and RLD2006 Tablets in Healthy Subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 (Reference-Test) | Experimental | Period 1: RLD2001-2 + RLD2006, Period2: HCP1904-1 |
|
| Sequence 2 (Test-Reference) | Experimental | Period 1:HCP1904-1, Period 2: RLD2001-2 + RLD2006 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HCP1904-1 | Drug | Take it once per period. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of Losartan | Pharmacokinetic evaluation | Day 1, Day 15: pre-dose(0 hour)~48hours |
| AUClast of Losartan | Pharmacokinetic evaluation | Day 1, Day 15: pre-dose(0 hour)~48hours |
| Cmax of EXP3174 | Pharmacokinetic evaluation | Day 1, Day 15: pre-dose(0 hour)~48hours |
| AUClast of EXP3174 | Pharmacokinetic evaluation | Day 1, Day 15: pre-dose(0 hour)~48hours |
| Cmax of Chlorthalidone | Pharmacokinetic evaluation | Day 1, Day 15: pre-dose(0 hour)~144hours |
| AUClast of Chlorthalidone | Pharmacokinetic evaluation | Day 1, Day 15:pre-dose(0 hour)~144hours |
| Measure | Description | Time Frame |
|---|---|---|
| AUC inf, Tmax, T1/2, Cl/F, Vd/F of Losartan | Pharmacokinetic evaluation | Day 1, Day 15: pre-dose(0 hour)~48hours |
| AUC inf, Tmax, T1/2, Cl/F, Vd/F of EXP3174 | Pharmacokinetic evaluation |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yangji Hospital | Seoul | South Korea |
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| RLD2006 | Drug | Take it once per period. |
|
| RLD2001-2 | Drug | Take it once per period. |
|
| Day 1, Day 15: pre-dose(0 hour)~48hours |
| AUC inf, Tmax, T1/2, Cl/F, Vd/F of Chlorthalidone | Pharmacokinetic evaluation | Day 1, Day 15:pre-dose(0 hour)~144hours |