A Sequence-randomized, Open-label, 3-way Crossover, Single Oral Dose Clinical Trial to Investigate the Pharmacokinetic Characteristics and Safety/Tolerability According to Formulations of CKD-386 in Healthy Male Volunteers
试验速览
- 阶段
- 1 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Cmax of each main component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 or D326, D337, D013
研究概览
简要总结
a study to investigate the pharmacokinetic characteristics and safety/tolerability according to formulations of CKD-386 in healthy male volunteers
详细描述
A sequence-randomized, open-label, 3-way crossover, single oral dose clinical trial to investigate the pharmacokinetic characteristics and safety/tolerability according to formulations of CKD-386 in healthy male volunteers
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
- 19 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers aged between ≥20 and ≤45 years old
- •Weight ≥ 50 kg, with calculated body mass index(BMI) of ≥ 18.5 and ≤ 27.0 kg/m2
- •Those who have no congenital chronic disease or chronic disease requiring treatment and who have no pathological symptoms or findings
- •Those who are judged to be eligible for clinical trials based on laboratory and ECG results during screening tests
- •Those who voluntarily decide to participate and agree to comply with the cautions after hearing and fully understanding the detailed description of this clinical trial
排除标准
- •History of presence of hepatobiliary, renal, cardiovascular, endocrine, respiratory, gastrointestinal, hematological, neurologic, psychiatric or musculoskeletal disorders affecting absorption, distribution, metabolism and excretion of the drug
- •Genetic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption
- •Those who are deemed unfit by the investigators to participate in the clinical trial for other reasons including the results of laboratory tests
研究组 & 干预措施
Sequence 1
Period 1: CKD-386 formulation 1(1 tab, once) / Period 2: CKD-386 formulation 2(1 tab, once) / Period 3: D326, D337, D013(3 tabs, once)
干预措施: CKD-386 formulation 1 (Drug)
Sequence 1
Period 1: CKD-386 formulation 1(1 tab, once) / Period 2: CKD-386 formulation 2(1 tab, once) / Period 3: D326, D337, D013(3 tabs, once)
干预措施: CKD-386 formulation 2 (Drug)
Sequence 1
Period 1: CKD-386 formulation 1(1 tab, once) / Period 2: CKD-386 formulation 2(1 tab, once) / Period 3: D326, D337, D013(3 tabs, once)
干预措施: D326, D337 and D013 (Drug)
Sequence 2
Period 1: CKD-386 formulation 1(1 tab, once) / Period 2: D326, D337, D013(3 tabs, once) / Period 3: CKD-386 formulation 2(1 tab, once)
干预措施: CKD-386 formulation 1 (Drug)
Sequence 2
Period 1: CKD-386 formulation 1(1 tab, once) / Period 2: D326, D337, D013(3 tabs, once) / Period 3: CKD-386 formulation 2(1 tab, once)
干预措施: CKD-386 formulation 2 (Drug)
Sequence 2
Period 1: CKD-386 formulation 1(1 tab, once) / Period 2: D326, D337, D013(3 tabs, once) / Period 3: CKD-386 formulation 2(1 tab, once)
干预措施: D326, D337 and D013 (Drug)
Sequence 3
Period 1: CKD-386 formulation 2(1 tab, once) / Period 2: D326, D337, D013(3 tabs, once) / Period 3: CKD-386 formulation 1(1 tab, once)
干预措施: CKD-386 formulation 1 (Drug)
Sequence 3
Period 1: CKD-386 formulation 2(1 tab, once) / Period 2: D326, D337, D013(3 tabs, once) / Period 3: CKD-386 formulation 1(1 tab, once)
干预措施: CKD-386 formulation 2 (Drug)
Sequence 3
Period 1: CKD-386 formulation 2(1 tab, once) / Period 2: D326, D337, D013(3 tabs, once) / Period 3: CKD-386 formulation 1(1 tab, once)
干预措施: D326, D337 and D013 (Drug)
Sequence 4
Period 1: CKD-386 formulation 2(1 tab, once) / Period 2: CKD-386 formulation 1(1 tab, once) / Period 3: D326, D337, D013
干预措施: CKD-386 formulation 1 (Drug)
Sequence 4
Period 1: CKD-386 formulation 2(1 tab, once) / Period 2: CKD-386 formulation 1(1 tab, once) / Period 3: D326, D337, D013
干预措施: CKD-386 formulation 2 (Drug)
Sequence 4
Period 1: CKD-386 formulation 2(1 tab, once) / Period 2: CKD-386 formulation 1(1 tab, once) / Period 3: D326, D337, D013
干预措施: D326, D337 and D013 (Drug)
Sequence 5
Period 1: D326, D337, D013(3 tabs, once) / Period 2: CKD-386 formulation 1(1 tab, once) / Period 3: CKD-386 formulation 2(1 tab, once)
干预措施: CKD-386 formulation 1 (Drug)
Sequence 5
Period 1: D326, D337, D013(3 tabs, once) / Period 2: CKD-386 formulation 1(1 tab, once) / Period 3: CKD-386 formulation 2(1 tab, once)
干预措施: CKD-386 formulation 2 (Drug)
Sequence 5
Period 1: D326, D337, D013(3 tabs, once) / Period 2: CKD-386 formulation 1(1 tab, once) / Period 3: CKD-386 formulation 2(1 tab, once)
干预措施: D326, D337 and D013 (Drug)
Sequence 6
Period 1: D326, D337, D013 (3 tabs, once)/ Period 2: CKD-386 formulation 2(1 tab, once) / Period 3: CKD-386 formulation 1(1 tab, once)
干预措施: CKD-386 formulation 1 (Drug)
Sequence 6
Period 1: D326, D337, D013 (3 tabs, once)/ Period 2: CKD-386 formulation 2(1 tab, once) / Period 3: CKD-386 formulation 1(1 tab, once)
干预措施: CKD-386 formulation 2 (Drug)
Sequence 6
Period 1: D326, D337, D013 (3 tabs, once)/ Period 2: CKD-386 formulation 2(1 tab, once) / Period 3: CKD-386 formulation 1(1 tab, once)
干预措施: D326, D337 and D013 (Drug)
结局指标
主要结局
Cmax of each main component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 or D326, D337, D013
时间窗: 0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31
Cmax: Maximum plasma concentration of the drug
AUC0-t of each main component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 or D326, D337, D013
时间窗: 0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31
AUC0-t: Area under the concentration-time curve from time zero to time
次要结局
- AUCinf each main component or the metabolite of the component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337, D013(0(predose)~72 hour at Day1~D3, Day15~D17, Day29~31)
- Tmax of each main component or the metabolite of the component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337, D013(0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31)
- t1/2 of each main component or the metabolite of the component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337, D013(0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31)
- CL/F of each main component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337, D013(0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31)
- Vd/F of each main component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337, D013(0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31)
- AUC0-t of the metabolite of each component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337, D013(0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31)
- Cmax of the metabolite of each component after single dose of CKD-386 formulation 1, CKD-386 formulation 2 and D326, D337, D013(0(predose)~72 hour at Day1~Day3, Day15~Day17, Day29~Day31)