Clinical Trial to Assess the Pharmacokinetic/Pharmacodynamic Characteristics and Safety/Tolerability of CKD-519 New Formulation in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Emax of CKD-519 CETP(Cholesteryl ester transfer protein) Activity
研究概览
简要总结
Study to assess the pharmacokinetic/pharmacodynamic characteristics and safety/tolerability to CKD-519 new formulation in healthy male subjects.
详细描述
Open-label, Randomized, 3-period, 6-sequence, crossover study
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Between 20 aged and 45 aged in healthy male adult
- •Body weight ≥ 50kg and in the range of calculated BMI(Body Mass Index) 18~29kg/m2
- •Subject who sign on an informed consent form willingly
- •Necessarily he agrees that use double contraceptions and do not sperm donation until two months during clinical trials and after the final dosage of investigational products
排除标准
- •Clinically significant disease with cardiovascular, respiratory, hepatobiliary, nephrological, hematological, gastrointestinal, endocrine, immune, integumentary, neurologic, psychiatric system
- •Have a acute disease within 28 days before the beginning of study treatment
- •Have a disease history that can effect drug absorption, distribution, metabolism, excretion
- •Have a clinically significant chronic disease
- •Systolic blood pressure <100mmHg or >140mmHg, diastolic blood pressure<60mmHg or >90mmHg
- •Positive for serology test (HBsAg, anti-HCV Ab, anti-HIV Ab, VDRL(Venereal Disease Research Laboratories))
- •Subject treated ethical drug within 14 days before the beginning of study treatment
- •Subject treated over-the-counter or herbal medicine within 7 days before the beginning of study treatment
- •Have a clinically significant allergic disease (except for mild allergic rhinitis, allergic dermatitis with no drugs)
- •Cannot take standard Meal
- •Whole blood donation within 60 days prior to the first dosing or component blood donation within 20 days prior to the first dosing
- •Blood transfusion within 30 days
- •Taking drugs have received any other investigational drug within 90 days prior to the first dosing
- •Continuously taking caffeine(>5 cups/day), drinking alcohol(>30g/day), smoking excessive cigarettes(>10cigarettes/day)
- •Impossible on who participants in clinical trial by investigator's decision including laboratory test result or another reasone(for example, noncompliance, a disobliging manner)
- •Subject treated metabolizing enzyme inducers or inhibitors including barbiturates within 30 days
研究组 & 干预措施
Group 1
A-B-C (Drug A: CKD-519 50mg 2Tabs. /Drug B: CKD-519 100mg 1Tab. /Drug C: CKD-519 100mg 1Cap.)
干预措施: CKD-519 50mg 2Tabs. (Drug)
Group 1
A-B-C (Drug A: CKD-519 50mg 2Tabs. /Drug B: CKD-519 100mg 1Tab. /Drug C: CKD-519 100mg 1Cap.)
干预措施: CKD-519 100mg 1Tab. (Drug)
Group 1
A-B-C (Drug A: CKD-519 50mg 2Tabs. /Drug B: CKD-519 100mg 1Tab. /Drug C: CKD-519 100mg 1Cap.)
干预措施: CKD-519 100mg 1Cap. (Drug)
Group 2
B-C-A (Drug A: CKD-519 50mg 2Tabs. /Drug B: CKD-519 100mg 1Tab. /Drug C: CKD-519 100mg 1Cap.)
干预措施: CKD-519 50mg 2Tabs. (Drug)
Group 2
B-C-A (Drug A: CKD-519 50mg 2Tabs. /Drug B: CKD-519 100mg 1Tab. /Drug C: CKD-519 100mg 1Cap.)
干预措施: CKD-519 100mg 1Tab. (Drug)
Group 2
B-C-A (Drug A: CKD-519 50mg 2Tabs. /Drug B: CKD-519 100mg 1Tab. /Drug C: CKD-519 100mg 1Cap.)
干预措施: CKD-519 100mg 1Cap. (Drug)
Group 3
C-A-B (Drug A: CKD-519 50mg 2Tabs. /Drug B: CKD-519 100mg 1Tab. /Drug C: CKD-519 100mg 1Cap.)
干预措施: CKD-519 50mg 2Tabs. (Drug)
Group 3
C-A-B (Drug A: CKD-519 50mg 2Tabs. /Drug B: CKD-519 100mg 1Tab. /Drug C: CKD-519 100mg 1Cap.)
干预措施: CKD-519 100mg 1Tab. (Drug)
Group 3
C-A-B (Drug A: CKD-519 50mg 2Tabs. /Drug B: CKD-519 100mg 1Tab. /Drug C: CKD-519 100mg 1Cap.)
干预措施: CKD-519 100mg 1Cap. (Drug)
Group 4
A-C-B (Drug A: CKD-519 50mg 2Tabs. /Drug B: CKD-519 100mg 1Tab. /Drug C: CKD-519 100mg 1Cap.)
干预措施: CKD-519 50mg 2Tabs. (Drug)
Group 4
A-C-B (Drug A: CKD-519 50mg 2Tabs. /Drug B: CKD-519 100mg 1Tab. /Drug C: CKD-519 100mg 1Cap.)
干预措施: CKD-519 100mg 1Tab. (Drug)
Group 4
A-C-B (Drug A: CKD-519 50mg 2Tabs. /Drug B: CKD-519 100mg 1Tab. /Drug C: CKD-519 100mg 1Cap.)
干预措施: CKD-519 100mg 1Cap. (Drug)
Group 5
B-A-C (Drug A: CKD-519 50mg 2Tabs. /Drug B: CKD-519 100mg 1Tab. /Drug C: CKD-519 100mg 1Cap.)
干预措施: CKD-519 50mg 2Tabs. (Drug)
Group 5
B-A-C (Drug A: CKD-519 50mg 2Tabs. /Drug B: CKD-519 100mg 1Tab. /Drug C: CKD-519 100mg 1Cap.)
干预措施: CKD-519 100mg 1Tab. (Drug)
Group 5
B-A-C (Drug A: CKD-519 50mg 2Tabs. /Drug B: CKD-519 100mg 1Tab. /Drug C: CKD-519 100mg 1Cap.)
干预措施: CKD-519 100mg 1Cap. (Drug)
Group 6
C-B-A (Drug A: CKD-519 50mg 2Tabs. /Drug B: CKD-519 100mg 1Tab. /Drug C: CKD-519 100mg 1Cap.)
干预措施: CKD-519 50mg 2Tabs. (Drug)
Group 6
C-B-A (Drug A: CKD-519 50mg 2Tabs. /Drug B: CKD-519 100mg 1Tab. /Drug C: CKD-519 100mg 1Cap.)
干预措施: CKD-519 100mg 1Tab. (Drug)
Group 6
C-B-A (Drug A: CKD-519 50mg 2Tabs. /Drug B: CKD-519 100mg 1Tab. /Drug C: CKD-519 100mg 1Cap.)
干预措施: CKD-519 100mg 1Cap. (Drug)
结局指标
主要结局
Emax of CKD-519 CETP(Cholesteryl ester transfer protein) Activity
时间窗: 0h, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 48h, 72h
Tmax of CKD-519
时间窗: 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 144h
Tmax of CKD-519 CETP Activity
时间窗: 0h, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 48h, 72h
AUEC of CKD-519 CETP Activity
时间窗: 0h, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 48h, 72h
AUClast of CKD-519
时间窗: 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 144h
AUC0-∞ of CKD-519
时间窗: 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 144h
CL/F of CKD-519
时间窗: 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 144h
Cmax of CKD-519
时间窗: 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 144h
t1/2 of CKD-519
时间窗: 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 144h
Vd/F of CKD-519
时间窗: 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 144h
EC50(half maximal effective concentration ) of CKD-519 CETP Activity
时间窗: 0h, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 48h, 72h
次要结局
未报告次要终点