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Safety and Pharmacokinetics of Probucol and Cilostazol

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ClinicalTrials.gov Identifier: NCT00549978
Recruitment Status : Completed
First Posted : October 26, 2007
Last Update Posted : July 23, 2010
Sponsor:
Collaborator:
Otsuka Pharmaceutical Co., Ltd.
Information provided by:
Korea Otsuka Pharmaceutical Co., Ltd.

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

Condition or disease Intervention/treatment Phase
Healthy Drug: Cilostazol Drug: Probucol Phase 4

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 32 participants
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase IV, Safety and Pharmacokinetics of Probucol and Cilostazol When Coadministered in Healthy Subjects
Study Start Date : October 2007
Actual Primary Completion Date : May 2008
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
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



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

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


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: October 26, 2007    Key Record Dates
Last Update Posted: July 23, 2010
Last Verified: July 2010

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

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