Bioavailability Study of DP-R202 in Healthy Male Volunteers Under Fed Conditions

NCT ID: NCT01421576

Last Updated: 2011-08-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2011-07-31

Brief Summary

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A randomized, open-label, single-dose, crossover clinical trial to evaluate the food effect on the pharmacokinetics of DP-R202 tablet after oral administration in healthy male volunteers.

Detailed Description

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The number of patient is twenty-four.Patients were randomly assigned either DP-R202(Sarpogrelate HCL 300mg, qd) under fasting condition or DP-R202(Sarpogrelate HCL 300mg, qd) after eating foods.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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High fat meal

Group Type ACTIVE_COMPARATOR

High fat meal

Intervention Type DIETARY_SUPPLEMENT

offer high fat-meal in the morning before drug intake.

DP-R202

under fed condition

Group Type EXPERIMENTAL

High fat meal

Intervention Type DIETARY_SUPPLEMENT

offer high fat-meal in the morning before drug intake.

Interventions

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High fat meal

offer high fat-meal in the morning before drug intake.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Other Names: DP-R202 : DP11002-3

Eligibility Criteria

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Inclusion Criteria

* 20 to 55 years of healthy volunteers

Exclusion Criteria

* Hypersensitivity Reaction about Sarpogrelate HCL or other antiplatelets
Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Alvogen Korea

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jae Wook Ko, M.D., Ph.D

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

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Samsung Medical Center

Seoul, Gangnam, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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DP-SACL-I-002

Identifier Type: -

Identifier Source: org_study_id

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