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

Alvogen Korea36 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

AnplagDRUG

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

Eligibility

Sex: MALEMin age: 20 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 20 to 55 years of healthy volunteers Exclusion Criteria: * Hypersensitivity Reaction about Sarpogrelate HCL or other antiplatelets

Locations (1)

Samsung Medical Center

Seoul, South Korea

Outcomes

Primary Outcomes

Cmax, AUClast

Time frame: 24h

Secondary Outcomes

tmax, t1/2, AUC0-∞

Time frame: 24h

Data from ClinicalTrials.gov

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