Pharmacokinetic / Pharmacodynamic (PK/PD) Study of Multiple Doses of DP-R202 in Healthy Volunteers

Alvogen

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Anplag

Study type: Interventional

Funder types: Industry

Identifiers

NCT01429688

DP-SACL-I-003

Details and patient eligibility

About

The purpose of this study is compare the safety and pharmacokinetic characteristics of DP-R202 (Sarpogrelate HCl 100mg, qd) with those of Anplag (Sarpogrelate HCl 100mg, tid) after multiple 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)3days first, DP-R202(Sarpogrelate HCL 300mg, qd) 3days Second or DP-R202(Sarpogrelate HCL 300mg, qd)3days first, anplag tablet(Sarpogrelate HCL 100mg, tid) 3days 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

DP-R202

Experimental group

Description:

Multiple oral administration for 3 days

Treatment:

Drug: Anplag

Anplag

Active Comparator group

Description:

Multiple oral administration for 3days

Treatment:

Drug: Anplag