Pharmacokinetics Study for Probucol

February 17, 2022 updated by: Korea Otsuka Pharmaceutical Co., Ltd.

A Randomized, Open-label, Single-center Clinical Trial to Evaluate the Safety and Pharmacokinetics of Probucol by Multiple Administration in Healthy Male Subjects

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 2
Group 2(probucol 500mg BID)
Drug: probucol
group 3: 250 mg 1 tablet in the morning and evening
Other Names:
  • Brand name: Lorelco
Drug: probucol
group 1: 250 mg
Other Names:
  • lorelco
Drug: probucol
group 2: 250 mg 2 tablets at once in the morning
Other Names:
  • Lorelco
ACTIVE_COMPARATOR: 1
Group 1(Probucol 250mg)
Drug: probucol
group 3: 250 mg 1 tablet in the morning and evening
Other Names:
  • Brand name: Lorelco
Drug: probucol
group 1: 250 mg
Other Names:
  • lorelco
Drug: probucol
group 2: 250 mg 2 tablets at once in the morning
Other Names:
  • Lorelco
ACTIVE_COMPARATOR: 3
Group 3(Probucol 500mg once daily)
Drug: probucol
group 3: 250 mg 1 tablet in the morning and evening
Other Names:
  • Brand name: Lorelco
Drug: probucol
group 1: 250 mg
Other Names:
  • lorelco
Drug: probucol
group 2: 250 mg 2 tablets at once in the morning
Other Names:
  • Lorelco

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Plasma pharmacokinetic (PK) parameters: Auc, Cmax etc.
Time Frame: 1 month
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Korea Otsuka Pharmaceutical Co., Ltd.

Investigators

  • Principal Investigator: Kyung-Sang Yoo, MD, PhD, Clinical Trial Center, Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (ACTUAL)

August 1, 2009

Study Completion (ACTUAL)

September 1, 2009

Study Registration Dates

First Submitted

October 18, 2009

First Submitted That Met QC Criteria

October 21, 2009

First Posted (ESTIMATE)

October 23, 2009

Study Record Updates

Last Update Posted (ACTUAL)

March 4, 2022

Last Update Submitted That Met QC Criteria

February 17, 2022

Last Verified

October 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 009-KOB-0801i

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Locations

3
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