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

September 6, 2011 updated by: Alvogen Korea

A Randomized, Single-dose, 2-sequence, 2-period Crossover Study to Investigate the Food-effect Pharmacokinetics of Sarpogrelate HCl Controlled Release Tablet in Healthy Male Subjects

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.

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)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

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

Yes

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: DP-R202
Multiple oral administration for 3 days
Drug: Anplag
Sarpogrelate HCl 300mg once a day or 100mg three times a day for 3 days
Other Names:
  • Other Names:
  • DP-R202 : DP11002-3
  • Anplag : 0007-1
ACTIVE_COMPARATOR: Anplag
Multiple oral administration for 3days
Drug: Anplag
Sarpogrelate HCl 300mg once a day or 100mg three times a day for 3 days
Other Names:
  • Other Names:
  • DP-R202 : DP11002-3
  • Anplag : 0007-1

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite of pharmacokinetics
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
Cmax, ss, AUCτ
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite of pharmacokinetics
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
tmax,ss, t1/2, Cav,ss, PTF, AI, Cmin,ss
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

Collaborators and Investigators

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

Sponsor

Alvogen Korea

Investigators

  • Principal Investigator: Jae Wook Ko, MD, PhD, 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

July 1, 2011

Primary Completion (ACTUAL)

August 1, 2011

Study Completion (ACTUAL)

August 1, 2011

Study Registration Dates

First Submitted

August 29, 2011

First Submitted That Met QC Criteria

September 6, 2011

First Posted (ESTIMATE)

September 7, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

September 7, 2011

Last Update Submitted That Met QC Criteria

September 6, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Other Study ID Numbers

  • DP-SACL-I-003

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.

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