Bioavailability Study of DP-R202 in Healthy Male Volunteers Under Fed Conditions
Overview
A randomized, open-label, single-dose, crossover clinical trial to evaluate the food effect on the pharmacokinetics of DP-R202 tablet after oral administration in healthy male volunteers.
Full Title of Study: “A Randomized, Single-dose, 2-sequence, 2-period Crossover Study to Investigate the Food-effect Pharmacokinetics of Sarpogrelate HCl Controlled Release Tablet in Healthy Male Subjects”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Study Primary Completion Date: July 2011
Detailed Description
The number of patient is twenty-four.Patients were randomly assigned either DP-R202(Sarpogrelate HCL 300mg, qd) under fasting condition or DP-R202(Sarpogrelate HCL 300mg, qd) after eating foods.
Interventions
- Dietary Supplement: High fat meal
- offer high fat-meal in the morning before drug intake.
Arms, Groups and Cohorts
- Active Comparator: High fat meal
- Experimental: DP-R202
- under fed condition
Clinical Trial Outcome Measures
Primary Measures
- Composite of Pharmacokinetics(Cmax, AUClast)
- Time Frame: 24h
Participating in This Clinical Trial
Inclusion Criteria
- 20 to 55 years of healthy volunteers Exclusion Criteria:
- Hypersensitivity Reaction about Sarpogrelate HCL or other antiplatelets
Gender Eligibility: Male
Minimum Age: 20 Years
Maximum Age: 55 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
Investigator Details
- Lead Sponsor
- Alvogen Korea
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Jae Wook Ko, M.D., Ph.D, Principal Investigator, Samsung Medical Center
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