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A randomized, open-label, single-dose, 2-sequence, 2-period, crossover clinical trial to investigate the bioequivalence between YHP2406 and YHR2501 in healthy volunteers
62 healthy subjects will be randomized to one of the 2 groups in the same ratio.
Subjects in group 1 will be administered "comparator" and "YHP2406" by crossover design on period 1, 2. Subjects in group 2 will be administered "YHP2406" and "comparator" by crossover design on period 1, 2.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A(RT) | Experimental | 31 subjects, Cross-over, Single dose YHR2501 on period 1, Single dose of YHP2406 on period 2 |
|
| B(TR) | Experimental | 31 subjects, Cross-over, Single dose of YHP2406 on period 1, Single dose of YHR2501 on period 2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YHP2406 | Drug | Test drug: YHP2406, Comparator: YHR2501 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma drug concentration-time curve [AUCt] | Area under the plasma drug concentration-time curve [AUCt] of Amoxicillin & Clavulanic acid | 0-8 hours |
| Maximum plasma concentration [Cmax] | Maximum plasma concentration [Cmax] of Amoxicillin & Clavulanic acid | 0-8 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 Amoxicillin & Clavulanic acid | 0-8 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 |
|---|---|---|
| Seoung Hyun Kang | H Plus Yangji Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| H Plus Yangji Hospital | Seoul | 08779 | South Korea |
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| YHR2501 |
| Drug |
Test drug: YHP2406, Comparator: YHR2501 |
|
Area under the plasma drug concentration-time curve/Area under the plasma drug concentration-time curve from time 0 to infinity [AUCt/AUCinf] of Amoxicillin & Clavulanic acid |
| 0-8 Hours |
| Time of peak concentration [Tmax] | Time of peak concentration [Tmax] of Amoxicillin & Clavulanic acid | 0-8 Hours |
| Terminal phase of half-life [t1/2] | Terminal phase of half-life [t1/2] of Amoxicillin & Clavulanic acid | 0-8 Hours |