The Pharmacokinetics and Safety Study of Probucol by Multiple Administration in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Pharmacokinetic parameters
研究概览
简要总结
The Objectives of this study is to evaluate the pharmacokinetics and safety of multiple oral doses of probucol in healthy male subjects.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
probucol in healthy male subjects
multiple oral doses of probucol in single group of healthy male subjects
干预措施: Probucol (Drug)
结局指标
主要结局
Pharmacokinetic parameters
时间窗: Day 1, 3, 5, 7, 9, 11, 12, 13, 14
Pharmacokinetic parameters: Day 1 (Plasma PK parameters over the 24h dosing period)： Cmax, Cmax1, Cmax2, tmax1, tmax2, AUC (0-10)h, AUC (10-24)h, AUC24h, C24h; Day3，5，7，9，11，12，13：C24h; Day 14： Cmax, Cmax1, Cmax2, tmax1, tmax2, AUC (0-10)h, AUC (10-24)h, AUC24h, C24h, Clast, tlast, t1/2,z,Lambdaz, DF, CL/F, Vz/F, AUC_%Extrap; Accumulation evaluation parameters: Rpred, R14,ac(AUC24h), R14,ac(Cmax), R14,ac(C24h), R14,ac\[AUC(0-10h)\], R14,ac\[AUC(10-24h)\], R14,ac(Cmax1), R14,ac(Cmax2).
次要结局
未报告次要终点