PKPD Study of Ticagrelor and Prasugrel in Healthy Korean Males
NCT ID: NCT01876797
Last Updated: 2014-03-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
12 participants
INTERVENTIONAL
2013-07-31
2013-08-31
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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ticagrelor-prasugrel
in period 1, 180 mg of ticagrelor will be administrated at a single oral dose. in period 2, 60 mg of prasugrel will be administrated at a single oral dose.
ticagrelor/prasugrel
Interventions
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ticagrelor/prasugrel
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
19 Years
45 Years
MALE
Yes
Sponsors
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Asan Medical Center
OTHER
Responsible Party
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Hyeong-Seok Lim
Assistant Professor
Principal Investigators
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Hyeong-Seok Lim, Professor
Role: PRINCIPAL_INVESTIGATOR
Asan Medical Center
Locations
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Asan Medical Center
Seoul, Seoul, South Korea
Countries
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References
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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.
Other Identifiers
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Hyeong-Seok Lim
Identifier Type: -
Identifier Source: org_study_id
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