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Comparative Pharmacokinetics Study of Clopidogrel and Aspirin Fixed-dose Combination Versus Separate Combination-2nd Trial

NCT ID: NCT01496261

Last Updated: 2011-12-21

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

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2011-09-30

Brief Summary

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The purpose of this study is to compare pharmacokinetics between fixed-dose combination and separate combination of clopidogrel 75mg/aspirin 100mg.

Detailed Description

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Conditions

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Coronary Artery Disease

Keywords

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Clopidogrel Aspirin Combination Pharmacokinetics Phase 1

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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Clopidogrel and Aspirin

Group Type ACTIVE_COMPARATOR

Clopidogrel and Aspirin

Intervention Type DRUG

Clopidogrel and Aspirin seperate combination, single dose

Coprigerl

Group Type EXPERIMENTAL

Fixed dose combination of clopidogrel/aspirin

Intervention Type DRUG

Fixed dose combination of clopidogrel/aspirin

Interventions

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Clopidogrel and Aspirin

Clopidogrel and Aspirin seperate combination, single dose

Intervention Type DRUG

Fixed dose combination of clopidogrel/aspirin

Fixed dose combination of clopidogrel/aspirin

Intervention Type DRUG

Other Intervention Names

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Clopidogrel: Plavix Aspirin: Astrix Coprigrel

Eligibility Criteria

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Inclusion Criteria

* A healthy male volunteer aged 20 to 55, and within 20% of ideal body weight.
* Have not any congenital or chronic diseases and medical symptom.
* Appropriate subject for the study judging from examinations(interview, vital signs, 12-lead ECG, physical examination, blood, urinalysis result on screening.
* Able to participate in the entire trial.
* Signed the informed consent form prior to study participation.

Exclusion Criteria

* Take metabolic enzyme inducing or inhibiting drugs like barbiturates within 28 days prior to the first IP administration.
* show evidence of acute disease within 28 days prior to the first IP administration.
* Have the medical history of bleeding symptom or bleeding disease
* Have the disease history(ex. Inflammatory intestinal disease, stomach or duodenum ulcer, liver and bowels disease, appendectomy except of gastrointestinal surgery history) that may influence on the absorption, distribution, metabolism and excretion of the drug.
* Have relevant hypersensitivity against drug or clinically significant allergic diseases except mild rhinitis that doesn't need medication.
* Have hypersensitivity reaction histories for Clopidogrel or aspirin.
* Have abnormal laboratory result. AST or ALT \> 1.25 times of upper limit/ Total bilirubin \> 1.5 times of upper limit/ PT, aPTT, BT over upper limit/ Platelet count \<150X10\^9/L or \>350X10\^9/L
* A drug abuse or a heavy caffeine consumer (more than 5cups per a day) or a heavy smoker (more than 10 cigarettes per a day) or a regular alcohol consumer(more than 30g/day) or drinking within 7days prior to the first IP administration.
* Have a diet(Especially, grapefruit juice-within 7days prior to the first IP administration) that may influence on the absorption, distribution, metabolism and excretion of the drug(s).
* Have donated whole blood within 60 days prior to the first IP administration.
* Participated in the other clinical trials within 90days prior to the first IP administration.
* Take medicine which affect to this trial within 10 days prior to the first IP administration.
* Appropriate subject for the trial judging from principal investigator.
Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Inje University

OTHER

Sponsor Role collaborator

Chong Kun Dang Pharmaceutical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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JL Ghim, Dr.

Role: PRINCIPAL_INVESTIGATOR

Inje University

Locations

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Inje University Pusan Paik Hospital

Jin-gu, Busan, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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132HPS11I

Identifier Type: -

Identifier Source: org_study_id