Safety and Pharmacokinetics of Probucol and Cilostazol

February 17, 2022 updated by: Korea Otsuka Pharmaceutical Co., Ltd.

Phase IV, Safety and Pharmacokinetics of Probucol and Cilostazol When Coadministered in Healthy Subjects

to investigate the safety and pharmacokinetics, in healthy adult male subjects

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Safety and Pharmacokinetics of Probucol and Cilostazol when co-administered in Health Subjects

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Clinical Trial Center, Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Korean
  • Gender: Male
  • Age: Over 20 and Under 40years, at time of informed consent
  • body weight: BMI over 19.0 and Under 25.0
  • Subjects who meet the following criteria at the time of the screening examination
  • Subjects who have given their written informed consent prior to participation in the study
  • Subjects who are reliable and willing to make themselves available for the duration of the study and follow the study protocol

Exclusion Criteria:

  • History or clinical evidence of significant respiratory, cardiovascular, renal, gastrointestinal, hepatic, endocrine, hematologic, neurologic, psychiatric, or other chronic disease, alcoholism, or drug abuse
  • Present or previous significant drug allergy to any prescription or over the counter medication
  • Blood collection exceeding 200ml within 4 weeks, 400ml within 12 weeks, or 1200ml within one year prior to scheduled study drug administration
  • Body weight: under 50Kg

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 1
Two compartments with cross-over and parallel
Drug: Cilostazol
cilostazol, then cilostazol/probucol
Other: 2
Two compartments with cross-over and parallel
Drug: Probucol
Probucol probucol/ cilostazol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetic parameters, Number of adverse events
Time Frame: during study follow-up period
during study follow-up period

Secondary Outcome Measures

Outcome Measure
Time Frame
Physical exam, ECG, Vital signs and Laboratory tests, Drug interaction parameters
Time Frame: During study follow-up period
During study follow-up period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Korea Otsuka Pharmaceutical Co., Ltd.

Collaborators

Otsuka Pharmaceutical Co., Ltd.

Investigators

  • Principal Investigator: In-Jin Jang, PhD, Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

May 1, 2008

Study Completion (Actual)

August 1, 2008

Study Registration Dates

First Submitted

October 25, 2007

First Submitted That Met QC Criteria

October 25, 2007

First Posted (Estimate)

October 26, 2007

Study Record Updates

Last Update Posted (Actual)

March 4, 2022

Last Update Submitted That Met QC Criteria

February 17, 2022

Last Verified

July 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 021-KOB-0702

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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