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The purpose of this study is compare the safety and pharmacokinetic characteristics of DP-R202 (Sarpogrelate HCl 100mg, qd) with those of Anplag (Sarpogrelate HCl 100mg, tid) after multiple oral administration in healthy male volunteers.
The number of patient is thirthy-six.Patients were randomly assigned either anplag tablet(Sarpogrelate HCL 100mg, tid)3days first, DP-R202(Sarpogrelate HCL 300mg, qd) 3days Second or DP-R202(Sarpogrelate HCL 300mg, qd)3days first, anplag tablet(Sarpogrelate HCL 100mg, tid) 3days second.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DP-R202 | Experimental | Multiple oral administration for 3 days |
|
| Anplag | Active Comparator | Multiple oral administration for 3days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anplag | Drug | Sarpogrelate HCl 300mg once a day or 100mg three times a day for 3 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Composite of pharmacokinetics | Cmax, ss, AUCÏ„ | comparator 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 6.33, 6.67, 7, 7.5, 8, 9, 12, 12.33, 12.67, 13, 13.5, 14, 15, 16, 24h Test drug : 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24h |
| Measure | Description | Time Frame |
|---|---|---|
| Composite of pharmacokinetics | tmax,ss, t1/2, Cav,ss, PTF, AI, Cmin,ss | comparator 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 6.33, 6.67, 7, 7.5, 8, 9, 12, 12.33, 12.67, 13, 13.5, 14, 15, 16, 24h Test drug : 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24h |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jae Wook Ko, MD, PhD | Samsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Seoul | South Korea |
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