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Pharmacokinetics Study for Probucol

Sponsor
Korea Otsuka Pharmaceutical Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT01000467
Collaborator
(none)
30
Enrollment
1
Location
3
Arms
7
Duration (Months)
4.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
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 Design

Study Type:
Interventional
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 :
Feb 1, 2009
Actual Primary Completion Date :
Aug 1, 2009
Actual Study Completion Date :
Sep 1, 2009

Arms and Interventions

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 Names:
  • Lorelco

    		•
    Active Comparator: 1

    Group 1(Probucol 250mg)

    Drug: probucol
    group 1: 250 mg
    Other Names:
  • lorelco

    		•
    Active Comparator: 3

    Group 3(Probucol 500mg once daily)

    Drug: probucol
    group 3: 250 mg 1 tablet in the morning and evening
    Other Names:
  • Brand name: Lorelco

    		•

    Outcome Measures

    Primary Outcome Measures

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 40 Years
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Korea Otsuka Pharmaceutical Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT01000467
    Other Study ID Numbers:
    • 009-KOB-0801i
    First Posted:
    Oct 23, 2009
    Last Update Posted:
    Mar 4, 2022
    Last Verified:
    Oct 1, 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:
    Probucol

    Study Results

    No Results Posted as of Mar 4, 2022