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An open-label, multiple-dosing, two-arms, one-sequence study to evaluate the safety and pharmacokinetics after co-administration of UIC201603 and UIC201604 in healthy volunteers
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Experimental | UIC201603 and co-administration of UIC201603 and UIC201604 |
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| Treatment B | Experimental | UIC201604 and co-administration of UIC201603 and UIC201604 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UIC201603 and co-administration of UIC201603 and UIC201604 | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| Plasma pharmacokinetics(AUCss,Ï„) of Cilostazol and Active metabolites(OPC-13015, OPC-13213) | Area under the serum drug concentration-time curve within a dosing interval at steady state | Day 7 and Day 21: -72, -48, -24, 0h, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24h |
| Plasma pharmacokinetics(Css,max) of Cilostazol and Active metabolites(OPC-13015, OPC-13213) | Maximum concentration of drug in serum at steady state | Day 7 and Day 21: -72, -48, -24, 0h, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24h |
| Plasma pharmacokinetics(AUCss,Ï„) of Rosuvastatin | Area under the serum drug concentration-time curve within a dosing interval at steady state | Day 7 and Day 21: -72, -48, -24, 0h, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24h |
| Plasma pharmacokinetics(Css,max) of Rosuvastatin | Maximum concentration of drug in serum at steady state | Day 7 and Day 21: -72, -48, -24, 0h, 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24h |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janghee Hong, M.D.,Ph.D | Chungnam National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chungnam National University Hospital | Daejeon | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39487337 | Derived | Kim DH, Hong JH, Jung WT, Nam KY, Roh JS, Lee HJ, Moon J, Kim KY, Jung JG, Sunwoo J. Pharmacokinetic Drug-Drug Interaction between Cilostazol and Rosuvastatin in Healthy Participants. Am J Cardiovasc Drugs. 2025 Mar;25(2):267-276. doi: 10.1007/s40256-024-00686-w. Epub 2024 Nov 2. |
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| UIC201604 and co-administration of UIC201603 and UIC201604 | Drug |
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