Safety and Pharmacokinetics of Probucol and Cilostazol

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

PHASE4

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2008-08-31

Brief Summary

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to investigate the safety and pharmacokinetics, in healthy adult male subjects

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Detailed Description

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Safety and Pharmacokinetics of Probucol and Cilostazol when co-administered in Health Subjects

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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1

Two compartments with cross-over and parallel

Group Type OTHER

Cilostazol

Intervention Type DRUG

cilostazol, then cilostazol/probucol

2

Two compartments with cross-over and parallel

Group Type OTHER

Probucol

Intervention Type DRUG

Probucol probucol/ cilostazol

Interventions

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Cilostazol

cilostazol, then cilostazol/probucol

Intervention Type DRUG

Probucol

Probucol probucol/ cilostazol

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Korean
* Gender: Male
* Age: Over 20 and Under 40years, at time of informed consent
* body weight: BMI over 19.0 and Under 25.0
* Subjects who meet the following criteria at the time of the screening examination
* Subjects who have given their written informed consent prior to participation in the study
* Subjects who are reliable and willing to make themselves available for the duration of the study and follow the study protocol

Exclusion Criteria

* History or clinical evidence of significant respiratory, cardiovascular, renal, gastrointestinal, hepatic, endocrine, hematologic, neurologic, psychiatric, or other chronic disease, alcoholism, or drug abuse
* Present or previous significant drug allergy to any prescription or over the counter medication
* Blood collection exceeding 200ml within 4 weeks, 400ml within 12 weeks, or 1200ml within one year prior to scheduled study drug administration
* Body weight: under 50Kg

Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes