Safety and Pharmacokinetic Characteristics of DP-R202 in Healthy Male Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Anplag

• Registration Number: NCT01421563
• Lead Sponsor: Alvogen Korea

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.

Study Timeline

• Study Start: 2011-02
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Study First Submitted: 2011-07-27
• Status Verified: 2011-08
• Study First Submitted QC: 2011-08-22
• Last Update Submitted: 2011-08-22
• Study First Posted: 2011-08-23
• Last Update Posted: 2011-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 36

Inclusion Criteria

• 20 to 55 years of healthy volunteers

Exclusion Criteria

• Hypersensitivity Reaction about Sarpogrelate HCL or other antiplatelets

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
DP-R202	Anplag	-
Anplag	Anplag	-

Primary Outcome Measures

Name	Time	Method
Cmax, AUClast	24h

Secondary Outcome Measures

Name	Time	Method
tmax, t1/2, AUC0-∞	24h

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of