A Randomized, Open Label, Single Dose, 2-way Crossover Clinical Trial to Evaluate the Pharmacokinetic Characteristics and Safety Between After Administration of a Fixed-dose Combination Drug of HCP2001 and Co-administration of Each Component in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- AUCt
研究概览
简要总结
The purpose of this study is to evaluate the pharmacokinetic characteristics and safety between HCP2001 and co-administration of each component in fasting and fed conditions respectively in healthy 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 54 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 19~54 years in healthy volunteers 19 kg/m^2 ≤ BMI < 28 kg/m^2, weight(men) ≥55kg / weight(women) ≥45kg
- •90 mmHg ≤ SBP <140 mmHg, 50 mmHg ≤ DBP <90 mmHg
- •agrees that the person, spouse, or partner uses appropriate medically recognized contraception and does not provide sperm or eggs from the date of administration of the first investigational drug to 7 days after the administration of the last investigational drug.
- •Subjects who voluntarily decides to participate in this clinical trial and agree in writing to ensure compliance with the clinical trial
排除标准
- •Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system
- •Subjects who judged ineligible by the investigator
研究组 & 干预措施
Sequence 3
Period 1: High fat diet + RLD2007 +RLD2008 + RLD2102
Period 2: High fat diet + HCP2001
干预措施: HCP2001 (Drug)
Sequence 3
Period 1: High fat diet + RLD2007 +RLD2008 + RLD2102
Period 2: High fat diet + HCP2001
干预措施: RLD2007 (Drug)
Sequence 1
Period 1: Fasted state + RLD2007 +RLD2008 + RLD2102
Period 2: Fasted state + HCP2001
干预措施: HCP2001 (Drug)
Sequence 1
Period 1: Fasted state + RLD2007 +RLD2008 + RLD2102
Period 2: Fasted state + HCP2001
干预措施: RLD2007 (Drug)
Sequence 1
Period 1: Fasted state + RLD2007 +RLD2008 + RLD2102
Period 2: Fasted state + HCP2001
干预措施: RLD2008 (Drug)
Sequence 1
Period 1: Fasted state + RLD2007 +RLD2008 + RLD2102
Period 2: Fasted state + HCP2001
干预措施: RLD2102 (Drug)
Sequence 2
Period 1: Fasted state + HCP2001
Period 2: Fasted state + RLD2007 +RLD2008 + RLD2102
干预措施: HCP2001 (Drug)
Sequence 2
Period 1: Fasted state + HCP2001
Period 2: Fasted state + RLD2007 +RLD2008 + RLD2102
干预措施: RLD2007 (Drug)
Sequence 2
Period 1: Fasted state + HCP2001
Period 2: Fasted state + RLD2007 +RLD2008 + RLD2102
干预措施: RLD2008 (Drug)
Sequence 2
Period 1: Fasted state + HCP2001
Period 2: Fasted state + RLD2007 +RLD2008 + RLD2102
干预措施: RLD2102 (Drug)
Sequence 3
Period 1: High fat diet + RLD2007 +RLD2008 + RLD2102
Period 2: High fat diet + HCP2001
干预措施: RLD2008 (Drug)
Sequence 3
Period 1: High fat diet + RLD2007 +RLD2008 + RLD2102
Period 2: High fat diet + HCP2001
干预措施: RLD2102 (Drug)
Sequence 4
Period 1: High fat diet + HCP2001
Period 2: High fat diet + RLD2007 +RLD2008 + RLD2102
干预措施: HCP2001 (Drug)
Sequence 4
Period 1: High fat diet + HCP2001
Period 2: High fat diet + RLD2007 +RLD2008 + RLD2102
干预措施: RLD2007 (Drug)
Sequence 4
Period 1: High fat diet + HCP2001
Period 2: High fat diet + RLD2007 +RLD2008 + RLD2102
干预措施: RLD2008 (Drug)
Sequence 4
Period 1: High fat diet + HCP2001
Period 2: High fat diet + RLD2007 +RLD2008 + RLD2102
干预措施: RLD2102 (Drug)
结局指标
主要结局
AUCt
时间窗: 0~48hr
Pharmacokinetic evaluation
Cmax
时间窗: 0~48hr
Pharmacokinetic evaluation
次要结局
- t1/2(0~48hr)
- CL/F(0~48hr)
- Vd/F(0~48hr)
- AUCinf(0~48hr)
- Tmax(0~48hr)