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

Alvogen Korea36 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

AnplagDRUG

Sarpogrelate HCl 300mg once a day or 100mg three times a day for 3 days

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

Composite of pharmacokinetics

Cmax, ss, AUCτ

Time frame: comparator 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 6.33, 6.67, 7, 7.5, 8, 9, 12, 12.33, 12.67, 13, 13.5, 14, 15, 16, 24h Test drug : 0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 16, 24h

Secondary Outcomes

Composite of pharmacokinetics

tmax,ss, t1/2, Cav,ss, PTF, AI, Cmin,ss

Data from ClinicalTrials.gov

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