Pharmacokinetics Study for Probucol

A Randomized, Open-label, Single-center Clinical Trial to Evaluate the Safety and Pharmacokinetics of Probucol by Multiple Administration in Healthy Male Subjects

To evaluate the safety and pharmacokinetics of probucol by multiple oral administration in healthy male subjects.

To evaluate the safety and pharmacokinetics of probucol by multiple oral administration of one 250-mg probucol tablet once daily after breakfast (250 mg/day), two 250-mg probucol tablets once daily after breakfast (500 mg/day), and one 250-mg probucol tablet twice daily after breakfast and dinner (500 mg/day) for 14 days in healthy male subjects.

Inclusion criteria

• Korean
• Male
• Age from 20 to 40 years at time of informed consent
• BMI more than 19.0 and less than 25.0
• Subjects who meet the following criteria at the time of the screening
• Subjects with ECG results without AV block and with both of qTc and QRS width within the standard values

Exclusion criteria

• History or clinical evidence of significant medical history
• Present or previous significant drug allergy to any prescription or OTC medication