Pharmacokinetics and Safety Study of Probucol by Multiple Administration in Healthy Male Subjects

This is a single dose, single period, multiple administration, open-labeled trial in one investigation center.

The screening examination will be completed from Day -14 to Day -2 before investigational medicinal product (IMP) administration. The subjects will be hospitalized on Day -1. From Day 1 (the next day), the subjects will receive probucol twice daily (BID). for 14 consecutive days. On Day 18, the subjects can be discharged after the safety evaluation. The follow-up visit will occur on Day 6, 9, 12, 15, 19, 27 (totally 41 days) after the final dosing day.

Inclusion criteria

• Chinese.
• Gender: Male.
• Age 20 to 40 years, (at time of informed consent).
• Body mass index [BMI, body weight (kg) / height (m)2] between 19 and 26 kg/m2, inclusive.
• Nonsmokers (or former smokers): Urinary cotinine level satisfying the criteria for a nonsmoker established by the trial site (at time of screening examination).
• Subjects judged by the investigator to be healthy based on the medical history, physical examination, vital signs, 12 lead ECG, the results of serological test (HIV/HCV Ab, HBsAg and Syphilis Ab) and clinical laboratory tests, etc.

Exclusion criteria

• Subjects with hypersensitivity or a history of hypersensitivity to any drug (any prescription or over-the-counter [OTC] drug)
• Subjects who meet any of the following lipid criteria in the fasting state (at time of screening examination)

• LDL-C: ≥ 140 mg/dL
• TC: ≥ 220 mg/dL
• HDL-C: < 40 mg/dL
• TG: ≥ 150 mg/dL

• LDL-C value will be directly measured or calculated by the Friedewald formula. Friedewald Formula: LDL-C = TC - HDL-C - TG/5 (When TG value is less than 400 mg/dL) LDL-C value will be directly measured when TG value is 400 mg/dL or greater.
• Subjects with electrocardiogram (ECG) results showing AV block or with both QTc and QRS width outside the standard values of the ECG laboratory (at time of screening examination)
• Subjects with alcohol or drug dependence or a history of drug abuse
• Subjects who have a positive result in an infectious disease test or urine drug test (at time of screening examination)
• Use of any of the following within the specified period prior to scheduled investigational medicinal product (IMP) administration

• All other prescription and OTC drugs (within 2 weeks prior to scheduled IMP administration)
• Alcohol and caffeine-containing products (within 1 week prior to scheduled IMP administration)
• Use of any other investigational drug within 16 weeks prior to scheduled IMP administration in the present trial
• Plasmapheresis or plateletpheresis within 2 weeks or whole blood collection (blood donation, etc) cumulatively exceeding 200 mL within 4 weeks, 400 mL within 12 weeks, or 1200 mL within 1 year prior to scheduled IMP administration
• Subjects whose body weight is less than 50 kg (at time of screening examination)
• Subjects who are scheduled for examination or treatment at any other hospital or clinic during the trial period
• Subjects otherwise judged by the investigator or sub investigator to be inappropriate for inclusion in the trial