Safety and Pharmacokinetic Characteristics of DP-R202 in... | NCT01421563

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

NCT01421563

Sponsor

Alvogen Korea

Status

Completed

Last Update Posted

Aug 23, 2011Estimated

Enrollment

36Actual

Phase

Phase 1

Conditions

Healthy

Interventions

Anplag

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2011

Primary Completion Date

Feb 2011Actual

Completion Date

Feb 2011Actual

First Submitted Date

Jul 27, 2011

First Submission Date that Met QC Criteria

Aug 22, 2011

First Posted Date

Aug 23, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 22, 2011

Last Update Posted Date

Aug 23, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

36Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Anplag	Active Comparator		Drug: Anplag
DP-R202	Experimental		Drug: Anplag

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Anplag	Drug	Sarpogrelate HCl 300mg once a day or 100mg three times a day	Anplag DP-R202

Measure	Description	Time Frame
Cmax, AUClast		24h

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

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

20 to 55 years of healthy volunteers

Exclusion Criteria:

Hypersensitivity Reaction about Sarpogrelate HCL or other antiplatelets

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
JaeWook Ko, M.D., Ph.D.	Samsung Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Samsung Medical Center		Seoul		135-710	South Korea