Safety and Pharmacokinetics of Probucol and Cilostazol

Otsuka

Status and phase: Completed; Phase 4

Conditions: Healthy

Treatments: Drug: Cilostazol; Drug: Probucol

Study type: Interventional

Funder types: Industry

Identifiers

NCT00549978

021-KOB-0702

Details and patient eligibility

About

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

Full description

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

Enrollment: 32 patients

Sex: Male

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

1

Other group

Description:

Two compartments with cross-over and parallel

Treatment:

Drug: Cilostazol

2

Other group

Description:

Two compartments with cross-over and parallel

Treatment:

Drug: Probucol