Safety and Pharmacokinetics of Probucol and Cilostazol

This study has been completed.

First Received: October 25, 2007 Last Updated: October 18, 2009 History of Changes

Sponsor:	Korea Otsuka Pharmaceutical Co.,Ltd.
Collaborator:	Otsuka Pharmaceutical Co., Ltd.
Information provided by:	Korea Otsuka Pharmaceutical Co.,Ltd.
ClinicalTrials.gov Identifier:	NCT00549978

Purpose

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

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

Study Type:	Interventional
Study Design:	Treatment, Open Label, Crossover Assignment, Pharmacokinetics Study
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: Probucol 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 National Clinical Trials Identifier (NCT ID):

Kim KP, Kim BH, Lim KS, Kim TE, Shin SG, Jang IJ, Yu KS. Potential interactions between cilostazol and probucol: a two-part, single-dose, open-label study in healthy Korean male volunteers. Clin Ther. 2009 Oct;31(10):2098-106.

Study ID Numbers:	021-KOB-0702
Study First Received:	October 25, 2007
Last Updated:	October 18, 2009
ClinicalTrials.gov Identifier:	NCT00549978 History of Changes
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:

Antimetabolites
Respiratory System Agents
Vasodilator Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Hematologic Agents
Fibrinolytic Agents
Neuroprotective Agents
Fibrin Modulating Agents
Therapeutic Uses
Cilostazol
Probucol

Antilipemic Agents
Anti-Asthmatic Agents
Enzyme Inhibitors
Anticholesteremic Agents
Cardiovascular Agents
Protective Agents
Pharmacologic Actions
Phosphodiesterase Inhibitors
Autonomic Agents
Platelet Aggregation Inhibitors
Peripheral Nervous System Agents
Central Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on February 08, 2010