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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-0064 | Other Identifier | Institutional review board of Asan Medical Center |
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An open label, parallel study to characterize the pharmacokinetics and pharmacodynamics of Prasugrel 30 mg or 60 mg in healthy male adult subjects
Screening
Enrollment and treatment randomization
Confinement to Research Unit from day - 1 to day 2
Outpatient visit : 2 times ( 48 and 73 hours after dosing)
Drug administration : Overnight Fasting
Blood sampling for PK, PD and genotyping
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 10 mg, 30 mg | Other | To compare PKPD of prasugrel 10 or 30 mg, 4 subjects will be given 10 mg of prasugrel (one tablet of 10 mg of Effient) on day 1 as a single oral dose and another 4 subjects will be given 30 mg of prasugrel (3 tablets of 10 mg of Effient) on day 1 as a single oral dose. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| prasugrel | Drug | prausugrel 10 or 30 mg will be administrated as single dose under overnight fast. |
|
| Measure | Description | Time Frame |
|---|---|---|
| plasma R-138727 and R-95913 concentrations | predose, 10 min, 15 min, 25 min, 0.5 h, 1 h, 1.5 h, 2 h, 2.5 h, 4 h, 6 h, 8 h, 12 h and 24 h after dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Maximal platelet aggregation | Maximal platelet aggregation will be measured by light transmission test | predose, 15 min, 0.5 h, 1 h, 2 h, 4 h, 8 h, 24 h, 48 h and 72 h after dosing |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Recruiting | Seoul | Seoul | 138-736 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25697420 | Derived | Jeon HS, Kim MJ, Choi HY, Kim YH, Kim EH, Kim AR, Park HJ, Bae KS, Lim HS. Pharmacokinetics and pharmacodynamics of ticagrelor and prasugrel in healthy male Korean volunteers. Clin Ther. 2015 Mar 1;37(3):563-73. doi: 10.1016/j.clinthera.2015.01.010. Epub 2015 Feb 16. |
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| ID | Term |
|---|---|
| D000068799 | Prasugrel Hydrochloride |
| D004341 | Drug Evaluation |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D010879 | Piperazines |
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| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000076722 | Drug Development |
| D008919 | Investigative Techniques |
| D005069 | Evaluation Studies as Topic |