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

Alvogen

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Anplag

Study type: Interventional

Funder types: Industry

Identifiers

NCT01421563

DP-SACL-I-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 patients

Sex: Male

Ages: 20 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 20 to 55 years of healthy volunteers

Exclusion criteria

• Hypersensitivity Reaction about Sarpogrelate HCL or other antiplatelets

Trial design

36 participants in 2 patient groups

Anplag

Active Comparator group

Treatment:

Drug: Anplag

DP-R202

Experimental group

Treatment:

Drug: Anplag