Skip to main content
OpenTrials
Completed

NCT Number: NCT01000467

Pharmacokinetics Study for Probucol

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

20 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Seoul national univeristy

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Probucol

Drug

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

Other names: Brand name: Lorelco

Primary outcomes

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

    Time frame: 1 month

Sponsors and collaborators

Lead sponsor

Korea Otsuka Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Oct 23, 2009
Registry last updated
Mar 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.