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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 CTL0901 and CTL0902 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 - Sequence AC | Experimental | Treatment A in Period 1 and Treatment C in Period 2 |
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| Arm B - Sequence BC | Experimental | Treatment B in Period 1 and Treatment C in Period 2 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drug: Treatment A | Drug | CTL0901, single dose, daily, repeated oral administration for 4 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUCÏ„,ss | predose(0 hour), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and, 24 hours postdose | |
| Cmax,ss | predose(0 hour), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and, 24 hours postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Tmax,ss | predose(0 hour), 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12 and, 24 hours postdose | |
| Cmin,ss | predose(0 hour), 0.25, 0.5, 0.75, 1, 1.25, 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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| Drug: Treatment B | Drug | CTL0902, single dose, daily, repeated oral administration for 7 days |
|
| Drug: Treatment C | Drug | CTL0901 and CTL0902, single dose, daily, repeated oral administration for 7 days |
|