Safety and Pharmacokinetics of Probucol and Cilostazol

Phase 4

Completed

• Conditions: Healthy
• Interventions: Drug: Probucol; Drug: Cilostazol

• Registration Number: NCT00549978
• Lead Sponsor: Korea Otsuka Pharmaceutical Co., Ltd.

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2007-10-25
• Study First Submitted QC: 2007-10-25
• Study First Posted: 2007-10-26
• Primary Completion: 2008-05
• Study Completion: 2008-08
• Status Verified: 2010-07
• Last Update Submitted: 2022-02-17
• Last Update Posted: 2022-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
2	Probucol	Two compartments with cross-over and parallel
1	Cilostazol	Two compartments with cross-over and parallel

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic parameters, Number of adverse events	during study follow-up period

Secondary Outcome Measures

Name	Time	Method
Physical exam, ECG, Vital signs and Laboratory tests, Drug interaction parameters	During study follow-up period

Trial Locations

Locations (1)

Clinical Trial Center, Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of