Trial | NCT01421563  Report issue

Title

Safety and Pharmacokinetic Characteristics of DP-R202 in Healthy Male Volunteers
A Randomized, Open-label, Two-Sequence, Two-Period Crossover Study to Assess the Pharmacokinetic Characteristics of Sarpogrelate HCl Controlled Release Tablet Compared With Sarpogrelate HCl Immediate Release Tablet in Healthy Male Subjects

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    36
The purpose of this study is compare the safety and pharmacokinetic characteristics of DP-R202 (Sarpogrelate HCl 300mg, qd) with those of Anplag (Sarpogrelate HCl 100mg, tid) after oral administration in healthy male volunteers.
The number of patient is thirthy-six.Patients were randomly assigned either anplag tablet(Sarpogrelate HCL 100mg, tid)first, DP-R202(Sarpogrelate HCL 300mg, qd) Second or DP-R202(Sarpogrelate HCL 300mg, qd) first, anplag tablet(Sarpogrelate HCL 100mg, tid) second.
Study Started
Feb 28
2011
Primary Completion
Feb 28
2011
Study Completion
Feb 28
2011
Last Update
Aug 23
2011
Estimate

Drug Anplag

Sarpogrelate HCl 300mg once a day or 100mg three times a day

  • Other names: DP-R202 : DP11002-2, Anplag : 0007

Anplag Active Comparator

DP-R202 Experimental

Criteria 

Inclusion Criteria:

20 to 55 years of healthy volunteers

Exclusion Criteria:

Hypersensitivity Reaction about Sarpogrelate HCL or other antiplatelets
No Results Posted