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OpenTrials
Completed

NCT Number: NCT00549978

Safety and Pharmacokinetics of Probucol and Cilostazol

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

Completed

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Key information

Conditions

Healthy

Age range

20 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Clinical Trial Center, Seoul National University Hospital

Seoul, 110-744, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cilostazol

Drug

cilostazol, then cilostazol/probucol

Probucol

Drug

Probucol probucol/ cilostazol

Primary outcomes

  1. Pharmacokinetic parameters, Number of adverse events

    Time frame: during study follow-up period

Secondary outcomes

  1. Physical exam, ECG, Vital signs and Laboratory tests, Drug interaction parameters

    Time frame: During study follow-up period

Sponsors and collaborators

Lead sponsor

Korea Otsuka Pharmaceutical Co., Ltd.

Industry

Collaborators

  • Otsuka Pharmaceutical Co., Ltd.

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Oct 26, 2007
Registry last updated
Mar 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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