Pharmacokinetics and Food Effect of Sarpogrelate HCl CR Formulation in Comparison to Immediate-release Formulation

April 23, 2013 updated by: Korea United Pharm. Inc.

A Randomized, Open-label, Single Dose, 3-Treatment, 3-Period Williams-Design to Assess the Pharmacokinetic Characteristics and Food Effect of Sarpogrelate HCl CR Tablets Compared With Sarpogrelate HCl IR Tablets in Healthy Male Subjects

The purpose of this study is to evaluate the pharmacokinetics of sarpogrelate controlled-release formulation (CR) in comparison to immediate-release formulation (IR) and Food effect on the pharmacokinetics of sarpogrelate CR.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 1

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

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Anplag
Sarpogrelate HCl 300mg once a day or 100mg three times a day
Drug: Anplag
Sarpogrelate HCl 300mg once a day or 100mg three times a day
Other Names:
  • UI03SPG300CT
Drug: UI03SPG300CT
Sarpogrelate HCl 300mg once a day or 100mg three times a day
Experimental: UI03SPG300CT
Sarpogrelate HCl 300mg once a day or 100mg three times a day
Drug: Anplag
Sarpogrelate HCl 300mg once a day or 100mg three times a day
Other Names:
  • UI03SPG300CT
Drug: UI03SPG300CT
Sarpogrelate HCl 300mg once a day or 100mg three times a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cmax
Time Frame: 24h
Active Comparator : predose(0), 0.25, 0.5, 1, 1.5, 2, 3, 6(immediately before 2nd drug intake) , 6.25, 6.5, 7, 7.5, 8, 9, 12(immediately before 3rd drug intake), 12.5, 13, 13.5, 14, 15, 16, 24 hours post-dose Experimental : predose(0), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24 hours post-dose
24h
AUCt
Time Frame: 24h
Active Comparator : predose(0), 0.25, 0.5, 1, 1.5, 2, 3, 6(immediately before 2nd drug intake) , 6.25, 6.5, 7, 7.5, 8, 9,12(immediately before 3rd drug intake), 12.5, 13, 13.5, 14, 15, 16, 24 hours post-dose Experimental : predose(0), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24 hours post-dose
24h

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
tmax, t1/2
Time Frame: 24h
Active Comparator : predose(0), 0.25, 0.5, 1, 1.5, 2, 3, 6(immediately before 2nd drug intake) , 6.25, 6.5, 7, 7.5, 8, 9, 12(immediately before 3rd drug intake), 12.5, 13, 13.5, 14, 15, 16, 24 hours post-dose Experimental : predose(0), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24 hours post-dose
24h
AUC0-∞
Time Frame: 24h
Active Comparator : predose(0), 0.25, 0.5, 1, 1.5, 2, 3, 6(immediately before 2nd drug intake) , 6.25, 6.5, 7, 7.5, 8, 9,12(immediately before 3rd drug intake), 12.5, 13, 13.5, 14, 15, 16, 24 hours post-dose Experimental : predose(0), 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24 hours post-dose
24h

Collaborators and Investigators

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

Sponsor

Korea United Pharm. Inc.

Investigators

  • Principal Investigator: Wooseong Huh, 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

September 1, 2011

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

April 21, 2013

First Submitted That Met QC Criteria

April 23, 2013

First Posted (Estimate)

April 26, 2013

Study Record Updates

Last Update Posted (Estimate)

April 26, 2013

Last Update Submitted That Met QC Criteria

April 23, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • KUP-SPG3-101

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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