NCT06357910已完成1 期
A Randomized, Open Label, Single Dose, Crossover Clinical Trial to Evaluate the Pharmacokinetic Characteristics and Safety After Administration of a Fixed-dose Combination Drug of HCP2303 and Co-administration of RLD2302 and RLD2102 in Healthy Volunteers Under Fed Conditions
Hanmi Pharmaceutical Company Limited1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2024年5月17日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 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 HCP2303 and co-administration of each component in fed condition 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
- •18.5 kg/m^2 ≤ BMI < 30 kg/m^2, weight(men) ≥55kg / weight(women) ≥45kg
- •90 mmHg ≤ sitSBP <140 mmHg, 50 mmHg ≤ sitDBP <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 cannot consume the high-fat meal provided during this clinical trial
- •Subjects who judged ineligible by the investigator
研究组 & 干预措施
Arm 1
Experimental
- Period1 : RLD2302 + RLD2102
- Period2 : HCP2303
干预措施: HCP2303 (Drug)
Arm 1
Experimental
- Period1 : RLD2302 + RLD2102
- Period2 : HCP2303
干预措施: RLD2302 (Drug)
Arm 1
Experimental
- Period1 : RLD2302 + RLD2102
- Period2 : HCP2303
干预措施: RLD2102 (Drug)
Arm 2
Experimental
- Period1 : HCP2303
- Period2 : RLD2302 + RLD2102
干预措施: HCP2303 (Drug)
Arm 2
Experimental
- Period1 : HCP2303
- Period2 : RLD2302 + RLD2102
干预措施: RLD2302 (Drug)
Arm 2
Experimental
- Period1 : HCP2303
- Period2 : RLD2302 + RLD2102
干预措施: RLD2102 (Drug)
结局指标
主要结局
AUCt
时间窗: 0~48 hours
Pharmacokinetic evaluation
Cmax
时间窗: 0~48 hours
Pharmacokinetic evaluation
次要结局
- t1/2(0~48 hours)
- CL/F(0~48 hours)
- Vd/F(0~48 hours)
- Tmax(0~48 hours)
- AUCinf(0~48 hours)
研究者
研究点 (1)
Loading locations...
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