NCT01000467

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_4 healthy

Timeline
Completed

Started Feb 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 18, 2009

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 23, 2009

Completed
Last Updated

March 4, 2022

Status Verified

October 1, 2009

Enrollment Period

6 months

First QC Date

October 18, 2009

Last Update Submit

February 17, 2022

Conditions

Healthy

Keywords

PK assessment for healthy male volunteerHealthy male subjects aged 20 to 40 years

Outcome Measures

Primary Outcomes (1)

  • Plasma pharmacokinetic (PK) parameters: Auc, Cmax etc.

    1 month

Study Arms (3)

2

ACTIVE COMPARATOR

Group 2(probucol 500mg BID)

Drug: probucol

1

ACTIVE COMPARATOR

Group 1(Probucol 250mg)

Drug: probucol

3

ACTIVE COMPARATOR

Group 3(Probucol 500mg once daily)

Drug: probucol

Interventions

probucolDRUG

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

Also known as: Brand name: Lorelco
3

Eligibility Criteria

Age20 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • History or clinical evidence of significant medical history
  • Present or previous significant drug allergy to any prescription or OTC medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul national univeristy

Seoul, South Korea

Location

MeSH Terms

Interventions

Probucol

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Kyung-Sang Yoo, MD, PhD

    Clinical Trial Center, Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 18, 2009

First Posted

October 23, 2009

Study Start

February 1, 2009

Primary Completion

August 1, 2009

Study Completion

September 1, 2009

Last Updated

March 4, 2022

Record last verified: 2009-10

Locations

KR(1)