Status:
COMPLETED
PKPD Study of Ticagrelor and Prasugrel in Healthy Korean Males
Lead Sponsor:
Asan Medical Center
Conditions:
Healthy
Eligibility:
MALE
19-45 years
Phase:
PHASE1
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 ...
Eligibility Criteria
Inclusion
- male aged 19 - 45 years at screening visit
- body weight at least 60 kg at screening visit
- body mass index 18 - 30 kg/m2
- SBP 90 - 149 mmHg and DBP 60 - 99 mmHg and pulse rate(beat per minute) 45 - 100 at screening visit
Exclusion
- any history of or having any clinically significant abnormalities
- any gastrointestinal disorder having impact on absorption of study drug
- any history of hypersensitivity of ticagrelor or prasugrel or compounds related study drugs
- 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
- any history of taking other study drug within 60 days before dosing
- 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
- any history of taking metabolic inducer or inhibitor
- overuse (caffeine: \> 5 units/day , alcohol: \> 21 units /week, smoking: \> 10 cigarettes/day)
- positive serology testy(Hbs antigen, HIV, Hepatitis C virus, Syphilis)
- any abnormality in clinical laboratory tests result or any ECG finding considered to be inadequate by investigator
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01876797
Start Date
July 1 2013
End Date
August 1 2013
Last Update
March 3 2014
Active Locations (1)
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1
Asan Medical Center
Seoul, Seoul, South Korea, 138-736