A Randomized, Open Label, Multiple Dose, Crossover Clinical Trial to Evaluate the Drug-drug Interaction and Safety Between HCP1306, RLD2302 and RLD2102 in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- AUCtau
研究概览
简要总结
The purpose of this study is to evaluate the drug-drug interaction and safety between HCP1306, RLD2302 and RLD2102 in healthy volunteers.
详细描述
[PART A] To evaluate the drug-drug interaction and safety between HCP1306, RLD2302
[PART B] To evaluate the drug-drug interaction and safety between HCP1306, RLD2302, RLD2102
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
- •18.5 kg/m^2 ≤ BMI < 30 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
[PART B] Single arm
Period1 : Treatment D (RLD2102) Period2 : Treatment C (HCP1306) Period3 : Treatment E (HCP1306, RLD2302, RLD2102)
干预措施: RLD2102 (Drug)
[PART A] Sequence 1
Period1 : Treatment A (HCP1306) Period2 : Treatment B (RLD2302) Period3 : Treatment C (HCP1306+RLD2302)
干预措施: HCP1306 (Drug)
[PART A] Sequence 1
Period1 : Treatment A (HCP1306) Period2 : Treatment B (RLD2302) Period3 : Treatment C (HCP1306+RLD2302)
干预措施: RLD2302 (Drug)
[PART A] Sequence 2
Period1 : Treatment C (HCP1306+RLD2302) Period2 : Treatment A (HCP1306) Period3 : Treatment B (RLD2302)
干预措施: HCP1306 (Drug)
[PART A] Sequence 2
Period1 : Treatment C (HCP1306+RLD2302) Period2 : Treatment A (HCP1306) Period3 : Treatment B (RLD2302)
干预措施: RLD2302 (Drug)
[PART A] Sequence 3
Period1 : Treatment B (RLD2302) Period2 : Treatment C (HCP1306+RLD2302) Period3 : Treatment A (HCP1306)
干预措施: HCP1306 (Drug)
[PART A] Sequence 3
Period1 : Treatment B (RLD2302) Period2 : Treatment C (HCP1306+RLD2302) Period3 : Treatment A (HCP1306)
干预措施: RLD2302 (Drug)
[PART A] Sequence 4
Period1 : Treatment C (HCP1306+RLD2302) Period2 : Treatment B (RLD2302) Period3 : Treatment A (HCP1306)
干预措施: HCP1306 (Drug)
[PART A] Sequence 4
Period1 : Treatment C (HCP1306+RLD2302) Period2 : Treatment B (RLD2302) Period3 : Treatment A (HCP1306)
干预措施: RLD2302 (Drug)
[PART A] Sequence 5
Period1 : Treatment B (RLD2302) Period2 : Treatment A (HCP1306) Period3 : Treatment C (HCP1306+RLD2302)
干预措施: HCP1306 (Drug)
[PART A] Sequence 5
Period1 : Treatment B (RLD2302) Period2 : Treatment A (HCP1306) Period3 : Treatment C (HCP1306+RLD2302)
干预措施: RLD2302 (Drug)
[PART A] Sequence 6
Period1 : Treatment A (HCP1306) Period2 : Treatment C (HCP1306+RLD2302) Period3 : Treatment B (RLD2302)
干预措施: HCP1306 (Drug)
[PART A] Sequence 6
Period1 : Treatment A (HCP1306) Period2 : Treatment C (HCP1306+RLD2302) Period3 : Treatment B (RLD2302)
干预措施: RLD2302 (Drug)
[PART B] Single arm
Period1 : Treatment D (RLD2102) Period2 : Treatment C (HCP1306) Period3 : Treatment E (HCP1306, RLD2302, RLD2102)
干预措施: HCP1306 (Drug)
[PART B] Single arm
Period1 : Treatment D (RLD2102) Period2 : Treatment C (HCP1306) Period3 : Treatment E (HCP1306, RLD2302, RLD2102)
干预措施: RLD2302 (Drug)
结局指标
主要结局
AUCtau
时间窗: [PART A] 0~72 hours, [PART B] 0~48hours after final dose administration
Pharmacokinetic evaluation
Css,max
时间窗: [PART A] 0~72 hours, [PART B] 0~48hours after final dose administration
Pharmacokinetic evaluation
次要结局
- Fluctuation[(Css,max-Css,min)/Css,av]([PART A] 0~72 hours, [PART B] 0~48hours after final dose administration)
- Css,min([PART A] 0~72 hours, [PART B] 0~48hours after final dose administration)
- Css,av([PART A] 0~72 hours, [PART B] 0~48hours after final dose administration)
- Tss,max([PART A] 0~72 hours, [PART B] 0~48hours after final dose administration)
- t1/2([PART A] 0~72 hours, [PART B] 0~48hours after final dose administration)
- CLss/F([PART A] 0~72 hours, [PART B] 0~48hours after final dose administration)
- Vdss/F([PART A] 0~72 hours, [PART B] 0~48hours after final dose administration)
- Swing[(Css,max-Css,min)/Css,min]([PART A] 0~72 hours, [PART B] 0~48hours after final dose administration)