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Safety and Pharmacokinetics of Probucol and Cilostazol

This study has been completed.
Sponsor:
Collaborator:
Otsuka Pharmaceutical Co., Ltd.
Information provided by:
Korea Otsuka Pharmaceutical Co.,Ltd.
ClinicalTrials.gov Identifier:
NCT00549978
First received: October 25, 2007
Last updated: July 21, 2010
Last verified: July 2010
History of Changes
  Purpose

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


Condition Intervention Phase
Healthy
 Drug: Cilostazol
Drug: Probucol
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase IV, Safety and Pharmacokinetics of Probucol and Cilostazol When Coadministered in Healthy Subjects

Resource links provided by NLM:

Drug Information available for: Cilostazol
U.S. FDA Resources

Further study details as provided by Korea Otsuka Pharmaceutical Co.,Ltd.:

Primary Outcome Measures:
  • Pharmacokinetic parameters, Number of adverse events [ Time Frame: during study follow-up period ]

Secondary Outcome Measures:
  • Physical exam, ECG, Vital signs and Laboratory tests, Drug interaction parameters [ Time Frame: During study follow-up period ]

Estimated Enrollment: 32
Study Start Date: October 2007
Study Completion Date: August 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Two compartments with cross-over and parallel
 Drug: Cilostazol
cilostazol, then cilostazol/probucol
2
Two compartments with cross-over and parallel
 Drug: Probucol
Probucol probucol/ cilostazol

Detailed Description:

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

  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00549978

Locations
Korea, Republic of
Clinical Trial Center, Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Korea Otsuka Pharmaceutical Co.,Ltd.
Otsuka Pharmaceutical Co., Ltd.
Investigators
Principal Investigator: In-Jin Jang, PhD Seoul National University Hospital
  More Information

No publications provided by Korea Otsuka Pharmaceutical Co.,Ltd.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00549978     History of Changes
Other Study ID Numbers: 021-KOB-0702
Study First Received: October 25, 2007
Last Updated: July 21, 2010
Health Authority: South Korea: Institutional Review Board

Keywords provided by Korea Otsuka Pharmaceutical Co.,Ltd.:
Safety and Pharmacokinetics in healthy subjects

Additional relevant MeSH terms:
Probucol
Cilostazol
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Antioxidants
Protective Agents
Physiological Effects of Drugs
Fibrinolytic Agents
Fibrin Modulating Agents
 Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Vasodilator Agents
Neuroprotective Agents
Central Nervous System Agents
Phosphodiesterase 3 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on May 23, 2013