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The purpose of this study is to explore the differences in pharmacokinetics and safety characteristics between Test Drugs(DWJ1439, DWJ1464) and that of Reference Drugs(DWC202003, DWC202004) in healthy adults.
The purpose of this study is to explore the differences in pharmacokinetics and safety characteristics between Test Drugs(DWJ1439, DWJ1464) and that of Reference Drugs(DWC202003, DWC202004) in healthy adults with fasting state: Randomized, open-label, oral, single-dose, four-treatment, three-period, non-replicated crossover study
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence A | Other | 7 subjects assigned to Sequence A will receive a single dose of 300mg DWJ1439 in period 1, 300mg DWC202003 in period 2 and 300mg DWJ1464 in period 3. |
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| Sequence B | Other | 7 subjects assigned to Sequence B will receive a single dose of 300mg DWJ1464 in period 1, 300mg DWC202004 in period 2 and 300mg DWC202003 in period 3. |
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| Sequence C | Other | 7 subjects assigned to Sequence C will receive a single dose of 300mg DWC202003 in period 1, 300mg DWJ1439 in period 2 and 300mg DWC202004 in period 3. |
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| Sequence D | Other | 7 subjects assigned to Sequence D will receive a single dose of 300mg DWC202004 in period 1, 300mg DWJ1464 in period 2 and 300mg DWJ1439 in period 3. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DWJ1439 | Drug | 300mg single dose |
| |
| Measure | Description | Time Frame |
|---|---|---|
| PK parameters of baseline corrected/uncorrected ursodeoxycholic acid: AUC0-t | Area under the plasma concentration-time curve from time 0 to time t | 0 - 72 hours after dosing |
| PK parameters of baseline corrected/uncorrected ursodeoxycholic acid: Cmax | Maximum plasma drug concentration | 0 - 72 hours after dosing |
| PK parameters of baseline corrected/uncorrected total ursodeoxycholic acid: AUC0-t | Area under the plasma concentration-time curve from time 0 to time t | 0 - 72 hours after dosing |
| PK parameters of baseline corrected/uncorrected total ursodeoxycholic acid: Cmax | Maximum plasma drug concentration | 0 - 72 hours after dosing |
| Measure | Description | Time Frame |
|---|---|---|
| PK parameters of baseline corrected/uncorrected ursodeoxycholic acid: AUCinf | Area under the plasma concentration-time curve from drug administration to drug elimination | 0 - 72 hours after dosing |
| PK parameters of baseline corrected/uncorrected ursodeoxycholic acid: Tmax |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bo-Hyung Kim | Contact | +82-2-958-9326 | bhkim98@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyung Hee University Medical Hospital | Recruiting | Seoul | South Korea |
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| DWJ1464 |
| Drug |
300mg single dose |
|
| DWC202003 | Drug | 300mg single dose |
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| DWC202004 | Drug | 300mg single dose |
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Time to reach maximum plasma concentration following drug administration |
| 0 - 72 hours after dosing |
| PK parameters of baseline corrected/uncorrected ursodeoxycholic acid: t1/2 | Elimination half-life | 0 - 72 hours after dosing |
| PK parameters of baseline corrected/uncorrected ursodeoxycholic acid: , Cl/F | Apparent total clearance of drug from plasma after oral administration | 0 - 72 hours after dosing |
| PK parameters of baseline corrected/uncorrected ursodeoxycholic acid: Vd/F | Apparent volume of distribution after oral administration | 0 - 72 hours after dosing |
| PK parameters of baseline corrected/uncorrected total ursodeoxycholic acid: AUCinf | Area under the plasma concentration-time curve from drug administration to drug elimination | 0 - 72 hours after dosing |
| PK parameters of baseline corrected/uncorrected total ursodeoxycholic acid: Tmax | Time to reach maximum plasma concentration following drug administration | 0 - 72 hours after dosing |
| PK parameters of baseline corrected/uncorrected total ursodeoxycholic acid: t1/2 | Elimination half-life | 0 - 72 hours after dosing |
| PK parameters of baseline corrected/uncorrected total ursodeoxycholic acid: Cl/F | Apparent total clearance of drug from plasma after oral administration | 0 - 72 hours after dosing |
| PK parameters of baseline corrected/uncorrected total ursodeoxycholic acid: Vd/F | Apparent volume of distribution after oral administration | 0 - 72 hours after dosing |