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

• Status: Unknown status
• Trial end date: 2014-02-01
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Asan Medical Center
• Treatments: Prasugrel Hydrochloride

Criteria

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