A Randomized, Open-label, Single Dose, 1-sequence, 3-treatment, 3-period Crossover Study to Investigate the Effects of Food on the Pharmacokinetics/Pharmacodynamics of CKD-519 in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Tmax of CKD-519
研究概览
简要总结
The purpose of this study is to investigate the effects of food on the pharmacokinetics/pharmacodynamics of CKD-519.
详细描述
A randomized, open-label, single dose, 1-sequence, 3-treatment, 3-period crossover study to investigate the effects of food on the pharmacokinetics/pharmacodynamics of CKD-519 in healthy male subjects.
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 adult male
- •Body weight more than 50, Body Mass Index between 18 and 29kg/m²
- •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
- •Those who fully understand about this clinical trials after enough hearing, and then decided to join the clinical trials by themselves and to comply with the precautions written consent
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
- •Defined by the following 12-lead ECG, QTc>450msec
- •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
- •Subject treated metabolizing enzyme inducers or inhibitors including barbiturates within 30 days
- •Continuously taking caffeine(caffeine>5 cups/day), drinking alcohol(alcohol>210g/week), smoking excessive cigarettes(cigarette>10cigarettes/day)
- •Impossible on who participants in clinical trial by investigator's decision including laboratory test result or another reasons(for example, noncompliance, a disobliging manner)
研究组 & 干预措施
CKD-519 tablet 100mg
CKD-519 tablet(formulation Ⅱ) 100mg(100mg X 1Tab) Period 1: CKD-519 100mg in fasted state Period 2:CKD-519 100mg with a standard meal Period 3:CKD-519 100mg with a high fat meal
干预措施: CKD-519 100mg (Drug)
CKD-519 tablet 200mg
CKD-519 tablet(formulation Ⅱ) 200mg(100mg X 2Tabs) Period 1:CKD-519 200mg in fasted state Period 2:CKD-519 200mg with a standard meal Period 3:CKD-519 200mg with a high fat meal
干预措施: CKD-519 200mg (Drug)
CKD-519 soft capsule 100mg
CKD-519 soft capsule(formulation Ⅲ) 100mg(100mg X 1Cap) Period 1:CKD-519 100mg in fasted state Period 2:CKD-519 100mg with a standard meal Period 3:CKD-519 100mg with a high fat meal
干预措施: CKD-519 100mg (Drug)
CKD-519 soft capsule 200mg
CKD-519 soft capsule(formulation Ⅲ) 200mg(100mg X 2Caps) Period 1:CKD-519 200mg in fasted state Period 2:CKD-519 200mg with a standard meal Period 3:CKD-519 200mg with a high fat meal
干预措施: CKD-519 200mg (Drug)
结局指标
主要结局
Tmax of CKD-519
时间窗: 0(predose)~168
CL/F of CKD-519
时间窗: 0(predose)~168
Cmax of CKD-519
时间窗: 0(predose)~168
AUCinf of CKD-519
时间窗: 0(predose)~168
T1/2 of CKD-519
时间窗: 0(predose)~168
AUClast of CKD-519
时间窗: 0(predose)~168
Vd/F of CKD-519
时间窗: 0(predose)~168
次要结局
- Inhibition of CETP(Cholesteryl ester transfer protein) Activity(0(predose)~168)