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to Evaluate the Safety and the Pharmacokinetic and Pharmacodynamic Interactions between JP-1366 and Clopidogrel, Aspirin, Atorvastatin and Apixaban
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 | Experimental | JP-1366 and clopidogrel |
|
| Part 2 | Experimental | JP-1366 and aspirin |
|
| Part 3 | Experimental | JP-1366 and atorvastatin |
|
| Part 4 | Experimental | JP-1366 and apixaban |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JP-1366 and clopidogrel | Drug | A randomized, open label, multiple-dosing, 6-sequence, 3-period, 3-treatment, crossover design |
|
| Measure | Description | Time Frame |
|---|---|---|
| [Part 1] Change in P2Y12 Reaction Unit (PRU) from baseline on day 8 | Change in P2Y12 Reaction Unit (PRU) | baseline on day 8 |
| [Part 2] Emax of arachidonic acid-induced platelet aggregation | Emax of arachidonic acid-induced platelet aggregation | up to 48 hours post-dose on Day 1 |
| [Part 2] AUEC0-24 of arachidonic acid-induced platelet aggregation | AUEC0-24 of arachidonic acid-induced platelet aggregation | up to 48 hours post-dose on Day 1 |
| [Part 2] Cmax,ss of JP-1366 | Cmax,ss of JP-1366 | up to 24 hours post-dose on Day 5 |
| [Part 2] AUCτ,ss of JP-1366 | AUCτ,ss of JP-1366 | up to 24 hours post-dose on Day 5 |
| [Part 2] Cmax of Aspirin | Cmax of Aspirin | up to 48 hours post-dose on Day 1 |
| [Part 2] AUClast of Aspirin | AUClast of Aspirin | up to 48 hours post-dose on Day 1 |
| [Part 3] Cmax,ss of JP-1366 | Cmax,ss of JP-1366 | up to 24 hours post-dose on Day 5 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cha University Bundang Medical Center | Recruiting | Seongnam-si | Gyeonggi-do | 13496 | South Korea |
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None (open label)
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| JP-1366 and aspirin | Drug | An open-label, multiple-dosing, fixed sequence, 3-period design |
|
| JP-1366 and atorvastatin | Drug | An open-label, multiple-dosing, fixed sequence, 3-period design Period 1: Atorvastatin |
|
| JP-1366 and apixaban | Drug | An open-label, multiple-dosing, fixed sequence, 3-period design |
|
| [Part 3] AUCτ,ss of JP-1366 | AUCτ,ss of JP-1366 | up to 24 hours post-dose on Day 5 |
| [Part 3] Cmax,ss of Atorvastatin | Cmax,ss of Atorvastatin | up to 24 hours post-dose on Day 5 |
| [Part 3] AUCτ,ss of Atorvastatin | AUCτ,ss of Atorvastatin | up to 24 hours post-dose on Day 5 |
| [Part 4] Emax of Anti-Factor Xa activity | Emax of Anti-Factor Xa activity | up to 48 hours post-dose on Day 5 |
| [Part 4] AUEC0-12 of Anti-Factor Xa activity | AUEC0-12 of Anti-Factor Xa activity | up to 48 hours post-dose on Day 5 |
| [Part 4] Cmax,ss of JP-1366 | Cmax,ss of JP-1366 | up to 24 hours post-dose on Day 5 |
| [Part 4] AUCτ,ss of JP-1366 | AUCτ,ss of JP-1366 | up to 24 hours post-dose on Day 5 |
| [Part 4] Cmax,ss of Apixaban | Cmax,ss of Apixaban | up to 12 hours post-dose on Day 5 |
| [Part 4] AUCτ,ss of Apixaban | AUCτ,ss of Apixaban | up to 12 hours post-dose on Day 5 |
| ID | Term |
|---|---|
| D000077144 | Clopidogrel |
| D001241 | Aspirin |
| D000069059 | Atorvastatin |
| C522181 | apixaban |
| ID | Term |
|---|---|
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
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