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

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

Detailed Description
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Screening Enrollment and treatment randomization Confinement to Research Unit from day - 1 to day 2 Outpatient visit : 2 times ( 48 and 73 hours after dosing) Drug administration : Overnight Fasting Blood sampling for PK, PD and genotyping PK: up to 24 hours after dosing PD: up to 72 hours after dosing

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

Conditions
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Healthy

Intervention / Treatment
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* Drug: prasugrel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 10 mg, 30 mg<br>To compare PKPD of prasugrel 10 or 30 mg, 4 subjects will be given 10 mg of prasugrel (one tablet of 10 mg of Effient) on day 1 as a single oral dose and another 4 subjects will be given 30 mg of prasugrel (3 tablets of 10 mg of Effient) on day 1 as a single oral dose. | Drug: prasugrel<br>* prausugrel 10 or 30 mg will be administrated as single dose under overnight fast.<br>* Other names: Effient 10 mg tablet will be used as study drug.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| plasma R-138727 and R-95913 concentrations |  | predose, 10 min, 15 min, 25 min, 0.5 h, 1 h, 1.5 h, 2 h, 2.5 h, 4 h, 6 h, 8 h, 12 h and 24 h after dosing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximal platelet aggregation | Maximal platelet aggregation will be measured by light transmission test | predose, 15 min, 0.5 h, 1 h, 2 h, 4 h, 8 h, 24 h, 48 h and 72 h after dosing | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Male, Korean, Healthy