Safety and Pharmacokinetics of Probucol and Cilostazol

• Sponsor: Korea Otsuka Pharmaceutical Co., Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00549978
• Collaborator: Otsuka Pharmaceutical Co., Ltd. (Industry)
• Enrollment: 32
• Location: 1
• Arms: 2
• Duration (Months): 10
• Patients Per Site Per Month: 3.2

Study Details

Study Description

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 Design

• Study Type: Interventional
• Actual Enrollment: 32 participants
• Allocation: Randomized
• 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: Oct 1, 2007
• Actual Primary Completion Date: May 1, 2008
• Actual Study Completion Date: Aug 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Other: 1 Two compartments with cross-over and parallel	Drug: Cilostazol; cilostazol, then cilostazol/probucol
Other: 2 Two compartments with cross-over and parallel	Drug: Probucol; Probucol probucol/ cilostazol

Outcome Measures

Primary Outcome Measures

1. Pharmacokinetic parameters, Number of adverse events [during study follow-up period]

Secondary Outcome Measures

1. Physical exam, ECG, Vital signs and Laboratory tests, Drug interaction parameters [During study follow-up period]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 40 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Korea Otsuka Pharmaceutical Co., Ltd.
• ClinicalTrials.gov Identifier: NCT00549978
• Other Study ID Numbers: 021-KOB-0702
• First Posted: Oct 26, 2007
• Last Update Posted: Mar 4, 2022
• Last Verified: Jul 1, 2010

• Keywords provided by Korea Otsuka Pharmaceutical Co., Ltd.: Safety and Pharmacokinetics in healthy subjects
• Additional relevant MeSH terms: Cilostazol; Probucol

Study Results

No Results Posted as of Mar 4, 2022