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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