Clinical Trial to Characterize Pharmacokinetic-pharmacodynamic (PKPD) of Prasugrel 10 mg or 30 mg in Healthy Volunteers

An Open Label, Single Dose Study to Characterize the Pharmacokinetics and Pharmacodynamics of Prasugrel in Healthy Male Adult Subjects

An open label, parallel study to characterize the pharmacokinetics and pharmacodynamics of Prasugrel 30 mg or 60 mg in healthy male adult subjects

1. Screening

2. Enrollment and treatment randomization

3. Confinement to Research Unit from day - 1 to day 2

4. Outpatient visit : 2 times ( 48 and 73 hours after dosing)

5. Drug administration : Overnight Fasting

6. Blood sampling for PK, PD and genotyping

   1. PK: up to 24 hours after dosing
   2. PD: up to 72 hours after dosing

Inclusion Criteria:

• male aged 19 to 45 years
• weigh over 60 kg
• body mass index 18 to 30 kg/m2

Exclusion Criteria:

• any history or state of clinically significant disease
• any gastrointestinal disease may interfere absorption of drug
• any history of hypersensitivity to prasugrel or other drug
• any history of taking herbal medication within 30 days before dosing or taking prescription medication within 14 days before dosing or taking over the counter drug within 7 days before dosing
• taking investigational drug within 60 days before dosing
• transfused within 30 days or donated blood within 60 days before dosing
• Positive serology test ( Hepatitis B surface antigen (HBs Ag), HIV, HCV)
• Clinically significant finding in laboratory result or electrocardiogram result