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An open-label, randomized, single-dose, oral administration, 2-sequence, 2- period, crossover study to evaluate bioequivalence between YHP2305 and YHR2404 in healthy subjects
Subjects in group A will be administered comparator and YHP2305 by crossover design on day 1, 8.
Subjects in group B will be administered YHP2305 and comparator by crossover design on day 1, 8.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A(RT) | Experimental | 17 subjects, Cross-over, Single dose of YHR2404 on day 1, Single dose of YHP2305 on day 8 |
|
| Group B(TR) | Experimental | 17 subjects, Cross-over, Single dose of YHP2305 on day 1, Single dose of YHR2404 on day 8 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YHP2305 | Drug | Test drug: YHP2305 Comparator: YHR2404 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma drug concentration-time curve [AUCt] | 0-36 hours | |
| Maximum plasma concentration [Cmax] | 0-36 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma drug concentration-time curve from time 0 to infinity [AUCinf] | 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] | 0-36 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Taegon Hong | Locations | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bumin Hospital | Seoul | 07590 | South Korea |
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Crossover Assignment two-way crossover
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| YHR2404 |
| Drug |
Test drug: YHP2305 comparator: YHR2404 |
|
| Time of peak concentration [Tmax] | 0-36 hours |
| Terminal phase of half-life [t1/2] | 0-36 hours |