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We decided to discontinue this particular clinical study through internal discussion.
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The purpose of this study is to evaluate the food effect on the pharmacokinetics of DWJ1458 after oral administration in healthy volunteers.
The purpose of this study is to evaluate the food effect on the pharmacokinetics of DWJ1458 after oral administration in healthy volunteers: Randomized, open-label, oral, single-dose, crossover study
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Subjects take DWJ1458 on a fasted condition, and after wash-out period, take DWJ1458 with a high-fat diet. |
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| Group 2 | Experimental | Subjects take DWJ1458 with a high-fat diet, and after wash-out period, take DWJ1458 on a fasted condition. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DWJ1458 (fasted) | Drug | Subjects take single dose of DWJ1458 on a fated condition |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic parameter of DWJ1458: AUC0-t | Area under the plasma concentration-time curve from time 0 to time t | 0 - 144 hours after dosing |
| Pharmacokinetic parameter of DWJ1458: Cmax | Maximum plasma drug concentration | 0 - 144 hours after dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic parameter of DWJ1458: AUCinf | Area under the plasma concentration-time curve from drug administration to drug elimination | 0 - 144 hours after dosing |
| Pharmacokinetic parameter of DWJ1458: Tmax |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yonsei University Health System, Severance Hospital | Seoul | South Korea |
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| DWJ1458 (fed) | Drug | Subjects take single dose of DWJ1458 after high-fat diet |
|
Time to reach maximum plasma concentration following drug administration
| 0 - 144 hours after dosing |
| Pharmacokinetic parameter of DWJ1458: t1/2 | Elimination half-life | 0 - 144 hours after dosing |
| Pharmacokinetic parameter of DWJ1458: Vd/F | Apparent volume of distribution after oral administration | 0 - 144 hours after dosing |
| Pharmacokinetic parameter of DWJ1458: Cl/F | Apparent total clearance of drug from plasma after oral administration | 0 - 144 hours after dosing |