Safety and Pharmacokinetics of Probucol and Cilostazol

• Status: Completed
• Trial end date: 2008-08-01
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Korea Otsuka Pharmaceutical Co., Ltd.
• Collaborator: Otsuka Pharmaceutical Co., Ltd.
• Treatments: Cilostazol; Probucol

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