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The purpose of this study is to evaluate the pharmacokinetics of sarpogrelate controlled-release formulation (CR) in comparison to immediate-release formulation (IR) and Food effect on the pharmacokinetics of sarpogrelate CR.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anplag | Active Comparator | Sarpogrelate HCl 300mg once a day or 100mg three times a day |
|
| UI03SPG300CT | Experimental | Sarpogrelate HCl 300mg once a day or 100mg three times a day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anplag | Drug | Sarpogrelate HCl 300mg once a day or 100mg three times a day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Active Comparator : predose(0), 0.25, 0.5, 1, 1.5, 2, 3, 6(immediately before 2nd drug intake) , 6.25, 6.5, 7, 7.5, 8, 9, 12(immediately before 3rd drug intake), 12.5, 13, 13.5, 14, 15, 16, 24 hours post-dose Experimental : predose(0), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24 hours post-dose | 24h |
| AUCt | Active Comparator : predose(0), 0.25, 0.5, 1, 1.5, 2, 3, 6(immediately before 2nd drug intake) , 6.25, 6.5, 7, 7.5, 8, 9,12(immediately before 3rd drug intake), 12.5, 13, 13.5, 14, 15, 16, 24 hours post-dose Experimental : predose(0), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24 hours post-dose | 24h |
| Measure | Description | Time Frame |
|---|---|---|
| tmax, t1/2 | Active Comparator : predose(0), 0.25, 0.5, 1, 1.5, 2, 3, 6(immediately before 2nd drug intake) , 6.25, 6.5, 7, 7.5, 8, 9, 12(immediately before 3rd drug intake), 12.5, 13, 13.5, 14, 15, 16, 24 hours post-dose Experimental : predose(0), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24 hours post-dose | 24h |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wooseong Huh, M.D., Ph.D. | Samsung Medical Center | Principal Investigator |
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| UI03SPG300CT | Drug | Sarpogrelate HCl 300mg once a day or 100mg three times a day |
|
| AUC0-∞ |
Active Comparator : predose(0), 0.25, 0.5, 1, 1.5, 2, 3, 6(immediately before 2nd drug intake) , 6.25, 6.5, 7, 7.5, 8, 9,12(immediately before 3rd drug intake), 12.5, 13, 13.5, 14, 15, 16, 24 hours post-dose Experimental : predose(0), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24 hours post-dose |
| 24h |