Pharmacokinetics Study for Probucol

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01000467
Recruitment Status : Completed
First Posted : October 23, 2009
Last Update Posted : October 23, 2009
Information provided by:
Korea Otsuka Pharmaceutical Co., Ltd.

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

Condition or disease Intervention/treatment Phase
Healthy Drug: probucol Phase 4

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  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : February 2009
Actual Primary Completion Date : August 2009
Actual Study Completion Date : September 2009

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Plasma pharmacokinetic (PK) parameters: Auc, Cmax etc. [ Time Frame: 1 month ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Responsible Party: Yonghui Jeong/Clinical Research Manager, Korea Otsuka Pharma Identifier: NCT01000467     History of Changes
Other Study ID Numbers: 009-KOB-0801i
First Posted: October 23, 2009    Key Record Dates
Last Update Posted: October 23, 2009
Last Verified: October 2009

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
Lipid Regulating Agents
Protective Agents
Physiological Effects of Drugs