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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01421563

Enrollment

Registered

2011-08-23

Start date

2011-02-28

Completion date

2011-02-28

Last updated

2011-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

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.

Detailed description

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.

Interventions

DRUGAnplag

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* 20 to 55 years of healthy volunteers

Exclusion criteria

* Hypersensitivity Reaction about Sarpogrelate HCL or other antiplatelets

Design outcomes

Primary

Measure	Time frame
Cmax, AUClast	24h

Secondary

Measure	Time frame
tmax, t1/2, AUC0-∞	24h

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026