Pharmacokinetics Study for Probucol

This study has been completed.
Information provided by:
Korea Otsuka Pharmaceutical Co.,Ltd. Identifier:
First received: October 18, 2009
Last updated: October 21, 2009
Last verified: October 2009

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

Condition Intervention Phase
Drug: probucol
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: A Randomized, Open-label, Single-center Clinical Trial to Evaluate the Safety and Pharmacokinetics of Probucol by Multiple Administration in Healthy Male Subjects

Further study details as provided by Korea Otsuka Pharmaceutical Co.,Ltd.:

Primary Outcome Measures:
  • Plasma pharmacokinetic (PK) parameters: Auc, Cmax etc. [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

Enrollment: 30
Study Start Date: February 2009
Study Completion Date: September 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 2
Group 2(probucol 500mg BID)
Drug: probucol
group 2: 250 mg 2 tablets at once in the morning
Other Name: Lorelco
Active Comparator: 1
Group 1(Probucol 250mg)
Drug: probucol
group 1: 250 mg
Other Name: lorelco
Active Comparator: 3
Group 3(Probucol 500mg once daily)
Drug: probucol
group 3: 250 mg 1 tablet in the morning and evening
Other Name: Brand name: Lorelco

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.


Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
Please refer to this study by its identifier: NCT01000467

Korea, Republic of
Seoul national univeristy
Seoul, Korea, Republic of
Sponsors and Collaborators
Korea Otsuka Pharmaceutical Co.,Ltd.
Principal Investigator: Kyung-Sang Yoo, MD, PhD Clinical Trial Center, Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Yonghui Jeong/Clinical Research Manager, Korea Otsuka Pharma Identifier: NCT01000467     History of Changes
Other Study ID Numbers: 009-KOB-0801i
Study First Received: October 18, 2009
Last Updated: October 21, 2009
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Korea Otsuka Pharmaceutical Co.,Ltd.:
PK assessment for healthy male volunteer
Healthy male subjects aged 20 to 40 years

Additional relevant MeSH terms:
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Protective Agents
Physiological Effects of Drugs processed this record on April 23, 2014