Pharmacokinetics Study for Probucol

NCT ID: NCT01000467

Last Updated: 2022-03-04

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

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2009-09-30

Brief Summary

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To evaluate the safety and pharmacokinetics of probucol by multiple oral administration in healthy male subjects.

Detailed Description

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To evaluate the safety and pharmacokinetics of probucol by multiple oral administration of one 250-mg probucol tablet once daily after breakfast (250 mg/day), two 250-mg probucol tablets once daily after breakfast (500 mg/day), and one 250-mg probucol tablet twice daily after breakfast and dinner (500 mg/day) for 14 days in healthy male subjects.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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2

Group 2(probucol 500mg BID)

Group Type ACTIVE_COMPARATOR

probucol

Intervention Type DRUG

group 2: 250 mg 2 tablets at once in the morning

1

Group 1(Probucol 250mg)

Group Type ACTIVE_COMPARATOR

probucol

Intervention Type DRUG

group 1: 250 mg

3

Group 3(Probucol 500mg once daily)

Group Type ACTIVE_COMPARATOR

probucol

Intervention Type DRUG

group 3: 250 mg 1 tablet in the morning and evening

Interventions

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probucol

group 3: 250 mg 1 tablet in the morning and evening

Intervention Type DRUG

probucol

group 1: 250 mg

Intervention Type DRUG

probucol

group 2: 250 mg 2 tablets at once in the morning

Intervention Type DRUG

Other Intervention Names

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Brand name: Lorelco lorelco Lorelco

Eligibility Criteria

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Inclusion Criteria

* Korean
* Male
* Age from 20 to 40 years at time of informed consent
* BMI more than 19.0 and less than 25.0
* Subjects who meet the following criteria at the time of the screening
* Subjects with ECG results without AV block and with both of qTc and QRS width within the standard values

Exclusion Criteria

* History or clinical evidence of significant medical history
* Present or previous significant drug allergy to any prescription or OTC medication
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Korea Otsuka Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kyung-Sang Yoo, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Clinical Trial Center, Seoul National University Hospital

Locations

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Seoul national univeristy

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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009-KOB-0801i

Identifier Type: -

Identifier Source: org_study_id

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