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This is a randomized, open, single-dose, crossover-design, phase 1, single-center study to evaluate bioequivalence after administration of L04RD1 or administration of L04TD1 in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A (L04RD1 -> L04TD1) | Experimental | Administration of 1 tablet of L04RD1, and taking 7-day wash-out period, and then administration of 1 tablet of L04TD1 |
|
| B (L04TD1 -> L04RD1) | Experimental | Administration of 1 tablet of L04TD1, and taking 7-day wash-out period, and then administration of 1 tablet of L04RD1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| L04RD1 | Drug | 1 tablet of L04RD1 |
| |
| L04TD1 |
| Measure | Description | Time Frame |
|---|---|---|
| AUCt | Pre-dose(0), 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00, 34.00, and 48.00 hours | |
| Cmax | Pre-dose(0), 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00, 34.00, and 48.00 hours |
| Measure | Description | Time Frame |
|---|---|---|
| AUCinf (Area under the plasma concentration-time curve from time 0 to infinity) | Pre-dose(0), 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00, 34.00, and 48.00 hours | |
| Tmax (Time of peak plasma concentration) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| H plus Yangji Hospital | Seoul | 08756 | South Korea |
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| Drug |
1 tablet of L04TD1 |
|
| L04TD1 | Drug | 1 tablet of L04TD1 |
|
| L04RD1 | Drug | 1 tablet of L04RD1 |
|
| Pre-dose(0), 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00, 34.00, and 48.00 hours |
| AUCt/AUCinf | Pre-dose(0), 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00, 34.00, and 48.00 hours |
| t1/2 (Half-life) | Pre-dose(0), 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00, 34.00, and 48.00 hours |
| CL/F | Pre-dose(0), 0.50, 1.00, 1.50, 2.00, 2.50, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00, 16.00, 24.00, 34.00, and 48.00 hours |