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The primary objective of this study is to assess the pharmacokinetic characteristics after a single dose of oral PBK-1801 in healthy Korean women for preparing the bridging data for Koreans.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
| |
| B | Experimental |
| |
| C | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PBK-1801 | Drug | Administered orally |
| |
| PBK-1801 |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | 5 days | |
| AUClast | 5 days | |
| AUCinf | 5 days | |
| Tmax | 5 days | |
| T1/2 | 5 days | |
| CL/F | 5 days | |
| Vd/F | 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| SeungHwan Lee | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea |
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| Drug |
Administered orally |
|
| PBK-1801 | Drug | Administered orally |
|