Clinical Trial to Characterize Pharmacokinetic-pharmacodynamic (PKPD) of Prasugrel 10 mg or 30 mg in Healthy Volunteers
Overview
An open label, parallel study to characterize the pharmacokinetics and pharmacodynamics of Prasugrel 30 mg or 60 mg in healthy male adult subjects
Full Title of Study: “An Open Label, Single Dose Study to Characterize the Pharmacokinetics and Pharmacodynamics of Prasugrel in Healthy Male Adult Subjects”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Study Primary Completion Date: February 2014
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
- Drug: prasugrel
- prausugrel 10 or 30 mg will be administrated as single dose under overnight fast.
Arms, Groups and Cohorts
- Other: 10 mg, 30 mg
- 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.
Clinical Trial Outcome Measures
Primary Measures
- 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 Measures
- Maximal platelet aggregation
- 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
- Maximal platelet aggregation will be measured by light transmission test
Participating in This Clinical Trial
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
Gender Eligibility: Male
Minimum Age: 19 Years
Maximum Age: 45 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
Investigator Details
- Lead Sponsor
- Asan Medical Center
- Provider of Information About this Clinical Study
- Principal Investigator: Hyeong-Seok Lim, Associate Professor – Asan Medical Center
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