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

NCT ID: NCT01841086

Last Updated: 2013-04-26

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

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2011-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Anplag

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

Group Type ACTIVE_COMPARATOR

Anplag

Intervention Type DRUG

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

UI03SPG300CT

Intervention Type DRUG

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

UI03SPG300CT

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

Group Type EXPERIMENTAL

Anplag

Intervention Type DRUG

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

UI03SPG300CT

Intervention Type DRUG

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

Interventions

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Anplag

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

Intervention Type DRUG

UI03SPG300CT

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

Intervention Type DRUG

Other Intervention Names

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UI03SPG300CT

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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Korea United Pharm. Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wooseong Huh, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Other Identifiers

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KUP-SPG3-101

Identifier Type: -

Identifier Source: org_study_id

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