Clopidogrel And Ticagrelor in Healthy Subjects

Pharmacodynamic Effect of Loading And Maintenance Doses Of Clopidogrel Versus Half Doses of Ticagrelor In Healthy Subjects

To evaluate the pharmacodynamics of a lower Ticagrelor dose in healthy Korean volunteers compared with standard Clopidogrel agent.

Consist with previous study Ticagrelor had greater, faster and more the platelet inhibition effect than Clopidogrel in both healthy subjects and stable coronary artery disease patients. Moreover, Asian subjects exposed higher active metabolite and stronger pharmacodynamics response than European subjects with same oral dose of antiplatelet agent. However, previous report comparing the efficacy and safety of Ticagrelor and Clopidogrel in healthy Asian ethnicity is lacking. Therefore, the aim of this study is to evaluate the pharmacodynamic responses of a lower Ticagrelor dose using laboratory platelet function tests in healthy Korean volunteers.

Inclusion Criteria:

• 12 healthy men
• Aged between 19 and 59 years
• Body mass index (BMI) is between 18.5 and 29.9 kg/m2
• Baseline maximal platelet aggregation (MPA) 10 μmol/L ADP is more than 65%
• To screen for standard results on usual clinical tests

Exclusion Criteria:

• A history of bleeding within 6 months
• Bleeding diathesis
• Hemoglobin < 12g/dl
• History of antiplatelet or anticoagulation treatment within 1 month
• contraindication to the study drug
• Severe hepatic dysfunction (serum liver enzyme or bilirubin >3 times normal limit)
• Patients with hereditary disease such as galactose intolerance, lactase deficiency, glucose-galactose malabsorption
• Previous experience of clinical trials within three months