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A randomized, open-label, single-dose, 2-sequence, 2-period, crossover clinical trial to investigate the bioequivalence between YHP2205 and YHR2401 in healthy volunteers
60 healthy subjects will be randomized to one of the 2 groups in the same ratio.
Subjects in group 1 will be administered "YHP2205" and "comparator" by crossover design on day 1, 8 Subjects in group 2 will be administered "comparator" and "YHP2205" by crossover design on day 1, 8.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence Group A | Experimental | 30 subjects, Cross-over, Single dose of YHR2401 on day 1, Single dose of YHP2205 on day 8 |
|
| Sequence Group B | Experimental | 30 subjects, Cross-over, Single dose of YHP2205 on day 1, Single dose of YHR2401 on day 8 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YHP2205 | Drug | Test drug: YHP2205 Comparator: YHR2401 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma drug concentration-time curve [AUCt] | Area under the plasma drug concentration-time curve [AUCt] of Edoxaban | 0-36 hours |
| Maximum plasma concentration [Cmax] | Maximum plasma concentration [Cmax] of Edoxaban | 0-36 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma drug concentration-time curve from time 0 to infinity [AUCinf] | Area under the plasma drug concentration-time curve from time 0 to infinity [AUCinf] of Edoxaban | 0-36 hours |
| Area under the plasma drug concentration-time curve/Area under the plasma drug concentration-time curve from time 0 to infinity [AUCt/AUCinf] |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bumin Hospital | Seoul | Gangseo-gu | 07590 | South Korea |
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Crossover Assignment two-way crossover
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| YHR2401 |
| Drug |
Test drug: YHP2205 Comparator: YHR2401 |
|
Area under the plasma drug concentration-time curve/Area under the plasma drug concentration-time curve from time 0 to infinity [AUCt/AUCinf] of Edoxaban |
| 0-36 hours |
| Time of peak concentration [Tmax] | Time of peak concentration [Tmax] of Edoxaban | 0-36 hours |
| Terminal phase of half-life [t1/2] | Terminal phase of half-life [t1/2] of Edoxaban | 0-36 hours |