Safety and Pharmacokinetics of Probucol and Cilostazol - Full Text View

Safety and Pharmacokinetics of Probucol and Cilostazol

This study is currently recruiting participants.
Verified by Korea Otsuka Pharmaceutical Co.,Ltd., November 2007

Sponsors and Collaborators:	Korea Otsuka Pharmaceutical Co.,Ltd. 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

ChemIDplus related topics:

Cilostazol Probucol

U.S. FDA Resources

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

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
Estimated Study Completion Date:	December 2007

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

Contacts


Contact: Yonghui Jeong	82-2-3465-3956	jeongyh@otsuka.co.kr

Contact: Boyoun Seo	82-2-3465-5485	byseo@otsuka.cokr

Locations


Korea, Republic of
	Clinical Trial Center, Seoul National University Hospital	Recruiting
	Seoul, Korea, Republic of, 110-744
	Principal Investigator: In-Jin Jang

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

Study ID Numbers:	021-KOB-0702
First Received:	October 25, 2007
Last Updated:	November 13, 2007
ClinicalTrials.gov Identifier:	NCT00549978
Health Authority:	South Korea: Institutional Review Board

Keywords provided by Korea Otsuka Pharmaceutical Co.,Ltd.:

Safety and Pharmacokinetics in healthy subjects

Study placed in the following topic categories:

Cilostazol

Probucol

Healthy

Additional relevant MeSH terms:

Antimetabolites

Respiratory System Agents

Vasodilator Agents

Antioxidants

Molecular Mechanisms of Pharmacological Action

Antilipemic Agents

Hematologic Agents

Physiological Effects of Drugs

Anti-Asthmatic Agents

Enzyme Inhibitors

Fibrinolytic Agents

Cardiovascular Agents

Anticholesteremic Agents

Neuroprotective Agents

Protective Agents

Pharmacologic Actions

Fibrin Modulating Agents

Phosphodiesterase Inhibitors

Autonomic Agents

Therapeutic Uses

Platelet Aggregation Inhibitors

Peripheral Nervous System Agents

Central Nervous System Agents

Bronchodilator Agents

ClinicalTrials.gov processed this record on October 17, 2008