NCT01421563

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Alvogen Korea · Industry
• Sex: Male
• Age: 20 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Anplag	Sarpogrelate HCl 300mg once a day or 100mg three times a day

Timeline

• Start date: 2011-02-01
• Primary completion: 2011-02-01
• Completion: 2011-02-01
• First posted: 2011-08-23
• Last updated: 2011-08-23

Locations

1 site across 1 country: South Korea