Pharmacokinetics Study for Probucol

This study has been completed.
Sponsor:
Information provided by:
Korea Otsuka Pharmaceutical Co.,Ltd.
ClinicalTrials.gov Identifier:
NCT01000467
First received: October 18, 2009
Last updated: October 21, 2009
Last verified: October 2009
  Purpose

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


Condition Intervention Phase
Healthy
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.

  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01000467

Locations
Korea, Republic of
Seoul national univeristy
Seoul, Korea, Republic of
Sponsors and Collaborators
Korea Otsuka Pharmaceutical Co.,Ltd.
Investigators
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
ClinicalTrials.gov 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:
Probucol
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Antioxidants
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 23, 2014