Healthy
Conditions
Brief summary
This study is to characterize the pharmacokinetic and pharmacodynamics of ticagrelor and prasugrel in healthy Korean male subjects. The study is open label, one sequence, crossover design. In period 1, a single oral dose of 180 mg ticagrelor will be administrated. After at least 7 days washout period, in period 2, a single oral dose of 60 mg prasugrel will be administrated. After dosing each period, blood sampling for PK and PD assessment will be conducted. 1. Blood Sampling Times 1. PK :predose,10 min,15 min,25 min, 0.5,1,1.5,2,2.5,4,6,8,12 and 24h post-dose 2. PD :predose,15 min,0.5,1,2,4,6,8,12 and 24h post-dose 2. Bioanalysis 1. plasma Ticagrelor 2. plasma AR-C124910XX (active metabolite of ticagrelor) 3. plasma R-95913 (inactive metabolite of prasugrel) 4. plasma R-13727 (active metabolite of prasugrel) 3. Platelet Aggregation Test using turbidometric Method Maximal Platelet Aggregation(MPA) 4. PK-PD Modeling analysis
Interventions
DRUGticagrelor/prasugrel
Sponsors
Asan Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
19 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. male aged 19 - 45 years at screening visit 2. body weight at least 60 kg at screening visit 3. body mass index 18 - 30 kg/m2 4. SBP 90 - 149 mmHg and DBP 60 - 99 mmHg and pulse rate(beat per minute) 45 - 100 at screening visit
Exclusion criteria
1. any history of or having any clinically significant abnormalities 2. any gastrointestinal disorder having impact on absorption of study drug 3. any history of hypersensitivity of ticagrelor or prasugrel or compounds related study drugs 4. any history of taking original medicines within 30 days before dosing or history of taking prescribed drug within 14 days before dosing or history of taking OTC drug within 7 days before dosing 5. any history of taking other study drug within 60 days before dosing 6. any history of whole blood transfusion within 60 days before dosing or history of blood elements transfusion or history of heaving been transfused within 30 days before 30 days 7. any history of taking metabolic inducer or inhibitor 8. overuse (caffeine: \> 5 units/day , alcohol: \> 21 units /week, smoking: \> 10 cigarettes/day) 9. positive serology testy(Hbs antigen, HIV, Hepatitis C virus, Syphilis) 10. any abnormality in clinical laboratory tests result or any ECG finding considered to be inadequate by investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| plasma ticagrelor parent,AR-C124910XX,R-95913 and R-13727 | 0,10 min,15 min,25 min,0.5h,1h,1.5h,2h,2.5h,4h,6h,8h,12h and 24h | 4 mL of blood will be drawn per each collection |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximal Platelet Aggregation(MPA) | 0,15 min,0.5 min, 1h,2h,4h,8h and 24h | platelet aggregation will be tested using light transmission aggregometry |
Other
| Measure | Time frame | Description |
|---|---|---|
| adverse event monitoring | up to 1 week | all adverse event will be collected |
Countries
South Korea
Outcome results
None listed