NCT07297693尚未招募1 期
An Open-label, Randomized, Single-dose, Oral Administration, 2-sequence, 2-period, Crossover Study to Evaluate the Pharmacokinetics and Safety Between HIP2503 and HCP1306 in Healthy Subjects
Hanmi Pharmaceutical Company Limited1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年12月19日最近更新:
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 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 HIP2503 and HCP1306 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 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 19~64 years in healthy volunteers
- •18 kg/m^2 ≤ BMI ≤ 30 kg/m^2, weight(men) ≥55kg / weight(women) ≥45kg
- •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 14 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
- •Subjects who judged ineligible by the investigator
研究组 & 干预措施
Arm 1
Experimental
- Period1 : HCP1306
- Period2 : HIP2503
干预措施: HIP2503 (Drug)
Arm 1
Experimental
- Period1 : HCP1306
- Period2 : HIP2503
干预措施: HCP1306 (Drug)
Arm 2
Experimental
- Period 1 : HIP2503
- Period 2 : HCP1306
干预措施: HIP2503 (Drug)
Arm 2
Experimental
- Period 1 : HIP2503
- Period 2 : HCP1306
干预措施: HCP1306 (Drug)
结局指标
主要结局
AUCt
时间窗: 0~72 hours
Pharmacokinetic evaluation
Cmax
时间窗: 0~72 hours
Pharmacokinetic evaluation
次要结局
- Ka(0~72 hours)
- Concentration/Cmax_%(0~72 hours)
- AUCinf(0~72 hours)
- AUCt/AUCinf(0~72 hours)
- Tmax(0~72 hours)
- t1/2(0~72 hours)
研究者
研究点 (1)
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