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

Phase 1UnknownNCT02075268

Asan Medical Center8 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

prasugrelDRUG

prausugrel 10 or 30 mg will be administrated as single dose under overnight fast.

Eligibility

Sex: MALEMin age: 19 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Asan Medical Center

Seoul, Seoul, South Korea

RECRUITING

Outcomes

Primary Outcomes

plasma R-138727 and R-95913 concentrations

Time frame: 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 Outcomes

Maximal platelet aggregation

Maximal platelet aggregation will be measured by light transmission test

Time frame: predose, 15 min, 0.5 h, 1 h, 2 h, 4 h, 8 h, 24 h, 48 h and 72 h after dosing

Data from ClinicalTrials.gov

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