NCT01429688

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Jul 2011

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

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

July 1, 2011

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

August 29, 2011

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 7, 2011

Completed
Last Updated

September 7, 2011

Status Verified

September 1, 2011

Enrollment Period

1 month

First QC Date

August 29, 2011

Last Update Submit

September 6, 2011

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Composite of pharmacokinetics

    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 Outcomes (1)

  • Composite of pharmacokinetics

    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

Study Arms (2)

DP-R202

EXPERIMENTAL

Multiple oral administration for 3 days

Drug: Anplag

Anplag

ACTIVE COMPARATOR

Multiple oral administration for 3days

Drug: Anplag

Interventions

AnplagDRUG

Sarpogrelate HCl 300mg once a day or 100mg three times a day for 3 days

Also known as: Other Names:, DP-R202 : DP11002-3, Anplag : 0007-1
AnplagDP-R202

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 Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

Study Officials

  • Jae Wook Ko, MD, PhD

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 29, 2011

First Posted

September 7, 2011

Study Start

July 1, 2011

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

September 7, 2011

Record last verified: 2011-09

Locations

KR(1)