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This study is a randomized, open label, single dose, two-way crossover clinical trial to investigate the pharmacokinetics and safety/tolerability of HCP1102 in comparison to HGP0813 and HGP1408 administered in healthy male volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Reference Drug → Test Drug |
|
| Group 2 | Experimental | Test Drug → Reference Drug |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| montelukast and levocetirizine FDC | Drug | HCP1102 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| AUClast of Montelukast | 1 Day 0 hour, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12 hour, 2 Day 0 hour, 3 Day 0 hour | |
| Cmax of Montelukast | 1 Day 0 hour, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12 hour, 2 Day 0 hour, 3 Day 0 hour | |
| AUClast of Levocetirizine | 1 Day 0 hour, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12 hour, 2 Day 0 hour, 3 Day 0 hour | |
| Cmax of Levocetirizine | 1 Day 0 hour, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12 hour, 2 Day 0 hour, 3 Day 0 hour |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chonbuk National University Hospital | Jeonju | Jeollabuk-do | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32271144 | Derived | Moon SJ, Yu KS, Jung J, Kim YI, Kim MG. Comparative pharmacokinetics of a montelukast/levocetirizine fixed-dose combination chewable tablet versus individual administration of montelukast and levocetirizine after a single oral administration in healthy Korean male subjects . Int J Clin Pharmacol Ther. 2020 Jun;58(6):354-362. doi: 10.5414/CP203709. |
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| ID | Term |
|---|---|
| C093875 | montelukast |
| C472067 | levocetirizine |
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| Singulair + xyzal |
| Drug |
HGP0813 + HGP1408 |
|