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

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02075268

Acronym

PRAS-AM

Enrollment

Registered

2014-03-03

Start date

2014-01-31

Completion date

2014-02-28

Last updated

2014-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Korean, Healthy, Male

Brief summary

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

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

Interventions

DRUGprasugrel

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

19 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	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

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 18, 2026