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

August 22, 2011 updated by: Alvogen Korea

A Randomized, Open-label, Two-Sequence, Two-Period Crossover Study to Assess the Pharmacokinetic Characteristics of Sarpogrelate HCl Controlled Release Tablet Compared With Sarpogrelate HCl Immediate Release Tablet in Healthy Male Subjects

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • 20 to 55 years of healthy volunteers

Exclusion Criteria:

  • Hypersensitivity Reaction about Sarpogrelate HCL or other antiplatelets

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Anplag
Drug: Anplag
Sarpogrelate HCl 300mg once a day or 100mg three times a day
Other Names:
  • DP-R202 : DP11002-2
  • Anplag : 0007
Experimental: DP-R202
Drug: Anplag
Sarpogrelate HCl 300mg once a day or 100mg three times a day
Other Names:
  • DP-R202 : DP11002-2
  • Anplag : 0007

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cmax, AUClast
Time Frame: 24h
24h

Secondary Outcome Measures

Outcome Measure
Time Frame
tmax, t1/2, AUC0-∞
Time Frame: 24h
24h

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alvogen Korea

Investigators

  • Principal Investigator: JaeWook Ko, M.D., Ph.D., Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

July 27, 2011

First Submitted That Met QC Criteria

August 22, 2011

First Posted (Estimate)

August 23, 2011

Study Record Updates

Last Update Posted (Estimate)

August 23, 2011

Last Update Submitted That Met QC Criteria

August 22, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Other Study ID Numbers

  • DP-SACL-I-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy

Clinical Trials on Anplag

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Greece

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe