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This study is to compare and evaluate the safety and pharmacokinetic characteristics (PK) after administration of SID1903 and SID1903-R1/SID1903-R2 in healthy adult volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence A | Experimental | Period 1: SID1903-R1, SID1903-R2 / Period 2: SID1903 |
|
| Sequence B | Experimental | - Period 1: SID1903 / Period 2: SID1903-R1, SID1903-R2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SID1903 | Drug | Single oral administration of SID1903 after an overnight fast |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-t | up to 72hours | |
| Cmax | up to 72hours |
| Measure | Description | Time Frame |
|---|---|---|
| Tmax | up to 72hours | |
| AUCinf | up to 72hours | |
| t1/2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chungbuk National University Hospital | Cheongju-si | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39179458 | Derived | Lukka PB, Tang W, Hammarstedt A, Conrad T, Heijer M, Karlsson C, Boulton DW. Racial Comparison of the Pharmacokinetics and Safety of Fixed-dose Combination of Dapagliflozin/Sitagliptin in Western and Korean Healthy Adults. Clin Ther. 2024 Sep;46(9):717-725. doi: 10.1016/j.clinthera.2024.07.007. Epub 2024 Aug 23. |
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| SID1903-R1/SID1903-R2 | Drug | Single oral administration of SID1903-R1 and SID1903-R2 after an overnight fast |
|
| up to 72hours |
| CL/F | up to 72hours |
| Vd/F | up to 72hours |
| λz | up to 72hours |
| MRT | up to 72hours |