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A bioequivalence study comparing DWJ1445 and DWC202506 in healthy adults
This is an open-label, randomized, single-dose, 2-treatment, 2-period, crossover, bioequivalence study conducted under fasting conditions to compare and evaluate the pharmacokinetics and safety of DWJ1445 and DWC202506 in healthy adult volunteers. Participants will receive both study drugs in separate periods, with a washout interval between administrations. The study aims to assess PK parameters and monitor safety through clinical evaluations and laboratory tests.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A(RT) | Experimental | 35 subjects, Cross-over, Single dose DWC202506 on period 1, Single dose of DWJ1445 on period 2 |
|
| B(TR) | Experimental | 35 subjects, Cross-over, Single dose DWJ1445 on period 1, Single dose of DWC202506 on period 2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DWJ1445 | Drug | 1 tablet, Orally |
| |
| DWC202506 |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma drug concentration-time curve [AUCt] | Area under the plasma drug concentration-time curve [AUCt] of DWJ1445 and DWC202506 | 0-24 hours |
| Maximum plasma concentration [Cmax] | Maximum plasma concentration [Cmax] of DWJ1445 and DWC202506 | 0-24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the plasma drug concentration-time curve from time 0 to infinity | Area under the plasma drug concentration-time curve from time 0 to infinity [AUCinf] of DWJ1445 and DWC202506 | 0-24 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 |
|---|---|---|---|---|---|---|
| H Plus Yangji Hospital | Seoul | South Korea |
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| Drug |
1 tablet, Orally |
|
Area under the plasma drug concentration-time curve/Area under the plasma drug concentration-time curve from time 0 to infinity [AUCt/AUCinf] of DWJ1445 and DWC202506 |
| 0-24 hours |
| Time of peak concentration [Tmax] | Time of peak concentration [Tmax] of Amoxicillin & Clavulanic acid of DWJ1445 and DWC202506 | 0-24 hours |
| Terminal phase of half-life [t1/2] | Terminal phase of half-life of DWJ1445 and DWC202506 | 0-24 hours |