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A randomized, open-label, single-dose, 2-sequence, 2-period, crossover clinical trial to investigate the bioequivalence between YHP2407 and YHR2502 in healthy volunteers
40 healthy subjects will be randomized to one of the 2 groups in the same ratio.
Subjects in group 1 will be administered "comparator" and "YHP2407" by crossover design on period 1, 2. Subjects in group 2 will be administered "YHP2407" and "comparator" by crossover design on period 1, 2.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A(RT) | Experimental | 20 subjects, Cross-over, Single dose YHR2502 on period 1, Single dose of YHP2407 on period 2 |
|
| B(TR) | Experimental | 20 subjects, Cross-over, Single dose of YHP2407 on period 1, Single dose of YHR2502 on period 2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YHP2407 | Drug | Test drug: YHP2407, Comparator: YHR2502 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma drug concentration-time curve [AUCt] | Area under the plasma drug concentration-time curve [AUCt] of Cefaclor Hydrate | 0-6 hours |
| Maximum plasma concentration [Cmax] | Maximum plasma concentration [Cmax] of Cefaclor Hydrate | 0-6 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 Cefaclor Hydrate | 0-6 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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| Name | Affiliation | Role |
|---|---|---|
| Hyejin Lim | Gimpo Woori Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gimpo Woori Hospital | Gimpo-si | Gyeonggi-do | 10099 | South Korea |
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| YHR2502 |
| Drug |
Test drug: YHP2407, Comparator: YHR2502 |
|
Area under the plasma drug concentration-time curve/Area under the plasma drug concentration-time curve from time 0 to infinity [AUCt/AUCinf] of Cefaclor Hydrate |
| 0-6 hours |
| Time of peak concentration [Tmax] | Time of peak concentration [Tmax] of Cefaclor Hydrate | 0-6 hours |
| Terminal phase of half-life [t1/2] | Terminal phase of half-life [t1/2] of Cefaclor Hydrate | 0-6 hours |