NCT07568652已完成1 期
A Randomized, Open-label, Single Oral Dose, Two-sequence, and Two-period Crossover Study to Evaluate the Pharmacokinetics and Safety Between the Single Administration of HL1113 and the Concomitant Administration of HL1113R1 and HL1113R2 for Healthy Subjects in Fasting State
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Cmax
研究概览
简要总结
This clinical trial is a randomized, open-label, single oral dose, two-sequence, and two-period crossover study to evaluate the pharmacokinetics and safety between the single administration of HL1113 and the concomitant administration of HL1113R1 and HL1113R2 for healthy subjects in fasting state
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects aged ≥19 years and <65 years at the time of screening
- •Subjects with a body mass index (BMI) of 18.0 to 30.0 kg/m² at screening(BMI calculated as: weight [kg] / height [m]²)
排除标准
- •Subjects who have taken medications known to markedly induce or inhibit drug-metabolizing enzymes (e.g., barbiturates) within 30 days prior to study initiation (first dose), or who have taken medications that may affect the outcome of the study within 10 days prior to study initiation (first dose). However, participation may be allowed if, based on pharmacokinetic/pharmacodynamic characteristics (e.g., drug interactions, half-life of concomitant medications), the investigator determines that such medications will not affect the study
- •Subjects who have participated in a bioequivalence study or any other clinical trial and received an investigational product within 6 months prior to study initiation (first dose)
研究组 & 干预措施
Test group 1
Experimental
干预措施: Test group 1 (Drug)
Test group 2
Experimental
干预措施: Test group 2 (Drug)
结局指标
主要结局
Cmax
时间窗: 48hr
Cmax
时间窗: 48 hours after administration
次要结局
- AUC∞(48hr)
- AUC∞(48 hours after administration)
研究者
研究点 (1)
Loading locations...
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