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This is a two-arm, open-label, single-sequence, multiple-dose, cross-over phase 1 study to evaluate the interaction between two investigational drugs by comparing and analyzing the pharmacokinetic interaction and safety of CTL0801 and CTL0802 at steady state when administered alone or in combination with repeated oral doses in healthy adult volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental | CTL0801 (Azilsartan) QD, 4days → CTL0801 (Azilsartan) + CTL0802 (Rosuvasatin) QD, 7days |
|
| Arm B | Experimental | CTL0802 (Rosuvasatin) QD, 7days → CTL0801 (Azilsartan) + CTL0802 (Rosuvasatin) QD, 7days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CTL0801 (Azilsartan) | Drug | CTL0801 (Azilsartan), single dose, daily, repeated oral administration |
| |
| Measure | Description | Time Frame |
|---|---|---|
| AUCÏ„,ss | predose(0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and, 24 hours postdose | |
| Cmax,ss | predose(0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and, 24 hours postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Tmax,ss | predose(0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and, 24 hours postdose | |
| Cmin,ss | predose(0 hour), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and, 24 hours postdose |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| H Plus Yangji Hospital | Seoul | South Korea |
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| ID | Term |
|---|---|
| C521273 | azilsartan |
| D000068718 | Rosuvastatin Calcium |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
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| CTL0802 (Rosuvastatin) |
| Drug |
CTL0802 (Rosuvastatin), single dose, daily, repeated oral administration |
|
| CTL0801 (Azilsartan) + CTL0802 (Rosuvastatin) | Drug | CTL0801 (Azilsartan) + CTL0802 (Rosuvastatin), single dose, daily, repeated oral administration |
|
| D006845 |
| Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |