NCT02075268

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (estimated)
• Sponsor: Asan Medical Center · Academic / Other
• Sex: Male
• Age: 19 Years – 45 Years
• Healthy volunteers: Accepted

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

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	prasugrel	prausugrel 10 or 30 mg will be administrated as single dose under overnight fast.

Timeline

• Start date: 2014-01-01
• Primary completion: 2014-02-01
• Completion: 2014-02-01
• First posted: 2014-03-03
• Last updated: 2014-03-04

Locations

1 site across 1 country: South Korea