to Evaluate the Safety and the Pharmacokinetic and Pharmacodynamic Interactions between JP-1366 and Clopidogrel, Aspirin, Atorvastatin and Apixaban
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
96
A randomized, open label, multiple-dosing, 6-sequence, 3-period, 3-treatment, crossover design
An open-label, multiple-dosing, fixed sequence, 3-period design
An open-label, multiple-dosing, fixed sequence, 3-period design Period 1: Atorvastatin
Cha University Bundang Medical Center
Seongnam-si, Gyeonggi-do, South Korea
RECRUITING[Part 1] Change in P2Y12 Reaction Unit (PRU) from baseline on day 8
Change in P2Y12 Reaction Unit (PRU)
Time frame: baseline on day 8
[Part 2] Emax of arachidonic acid-induced platelet aggregation
Emax of arachidonic acid-induced platelet aggregation
Time frame: 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
Time frame: up to 48 hours post-dose on Day 1
[Part 2] Cmax,ss of JP-1366
Cmax,ss of JP-1366
Time frame: up to 24 hours post-dose on Day 5
[Part 2] AUCτ,ss of JP-1366
AUCτ,ss of JP-1366
Time frame: up to 24 hours post-dose on Day 5
[Part 2] Cmax of Aspirin
Cmax of Aspirin
Time frame: up to 48 hours post-dose on Day 1
[Part 2] AUClast of Aspirin
AUClast of Aspirin
Time frame: up to 48 hours post-dose on Day 1
[Part 3] Cmax,ss of JP-1366
Cmax,ss of JP-1366
Time frame: up to 24 hours post-dose on Day 5
[Part 3] AUCτ,ss of JP-1366
AUCτ,ss of JP-1366
Time frame: up to 24 hours post-dose on Day 5
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An open-label, multiple-dosing, fixed sequence, 3-period design
[Part 3] Cmax,ss of Atorvastatin
Cmax,ss of Atorvastatin
Time frame: up to 24 hours post-dose on Day 5
[Part 3] AUCτ,ss of Atorvastatin
AUCτ,ss of Atorvastatin
Time frame: up to 24 hours post-dose on Day 5
[Part 4] Emax of Anti-Factor Xa activity
Emax of Anti-Factor Xa activity
Time frame: 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
Time frame: up to 48 hours post-dose on Day 5
[Part 4] Cmax,ss of JP-1366
Cmax,ss of JP-1366
Time frame: up to 24 hours post-dose on Day 5
[Part 4] AUCτ,ss of JP-1366
AUCτ,ss of JP-1366
Time frame: up to 24 hours post-dose on Day 5
[Part 4] Cmax,ss of Apixaban
Cmax,ss of Apixaban
Time frame: up to 12 hours post-dose on Day 5
[Part 4] AUCτ,ss of Apixaban
AUCτ,ss of Apixaban
Time frame: up to 12 hours post-dose on Day 5