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

NCT ID: NCT01421563

Last Updated: 2011-08-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2011-02-28

Brief Summary

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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

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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

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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Anplag

Group Type ACTIVE_COMPARATOR

Anplag

Intervention Type DRUG

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

DP-R202

Group Type EXPERIMENTAL

Anplag

Intervention Type DRUG

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

Interventions

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Anplag

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

Intervention Type DRUG

Other Intervention Names

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DP-R202 : DP11002-2 Anplag : 0007

Eligibility Criteria

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Inclusion Criteria

* 20 to 55 years of healthy volunteers

Exclusion Criteria

* Hypersensitivity Reaction about Sarpogrelate HCL or other antiplatelets
Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Alvogen Korea

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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JaeWook Ko, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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DP-SACL-I-001

Identifier Type: -

Identifier Source: org_study_id

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