Safety and Pharmacokinetics of Probucol and Cilostazol

Phase IV, Safety and Pharmacokinetics of Probucol and Cilostazol When Coadministered in Healthy Subjects

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00549978

Enrollment

Registered

2007-10-26

Start date

2007-10-31

Completion date

2008-08-31

Last updated

2022-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Safety and Pharmacokinetics in healthy subjects

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

Interventions

DRUGCilostazol

cilostazol, then cilostazol/probucol

DRUGProbucol

Probucol probucol/ cilostazol

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to 40 Years

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

Design outcomes

Primary

Measure	Time frame
Pharmacokinetic parameters, Number of adverse events	during study follow-up period

Secondary

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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 2, 2026