NCT01841086

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Sep 2011

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

April 21, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 26, 2013

Completed
Last Updated

April 26, 2013

Status Verified

April 1, 2013

Enrollment Period

2 months

First QC Date

April 21, 2013

Last Update Submit

April 23, 2013

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • Cmax

    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

    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 Outcomes (2)

  • tmax, t1/2

    24h

  • AUC0-∞

    24h

Study Arms (2)

Anplag

ACTIVE COMPARATOR

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

Drug: AnplagDrug: UI03SPG300CT

UI03SPG300CT

EXPERIMENTAL

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

Drug: AnplagDrug: UI03SPG300CT

Interventions

AnplagDRUG

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

Also known as: UI03SPG300CT
AnplagUI03SPG300CT
UI03SPG300CTDRUG

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

AnplagUI03SPG300CT

Eligibility Criteria

Age20 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • to 55 years of healthy volunteers

You may not qualify if:

  • Hypersensitivity Reaction about Sarpogrelate HCl or other antiplatelets

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Wooseong Huh, M.D., Ph.D.

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2013

First Posted

April 26, 2013

Study Start

September 1, 2011

Primary Completion

November 1, 2011

Study Completion

December 1, 2011

Last Updated

April 26, 2013

Record last verified: 2013-04