An Open-label, Randomized, Single Administration, Full Replicated Crossover Phase 1 Clinical Trial to Compare Pharmacokinetics and Safety Between JLP-1901 and JC-001 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Cmax of JLP-1901
研究概览
简要总结
To evaluate the safety and pharmacokinetic characteristics after the administration of JC-001 and JLP-1901
详细描述
An open-label, randomized, single administration, full replicated crossover phase 1 clinical trial to compare pharmacokinetics and safety between JLP-1901 and JC-001 in healthy subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Healthy adults over 19 years of age and under 65 years of age at the time of screening test
- •Those with a body mass index (BMI) of 17.5 kg/m2 or more but less than 30.5 kg/m2 and a body weight of 55 kg or more for men and 45 kg or more for women.
- •Those who do not have congenital or chronic diseases within the past 3 years and have no pathological symptoms or findings as a result of internal medical examination
- •Subjects determined to be suitable as a trial subject as a result of tests performed during screening, such as laboratory tests (hematology test, blood chemistry test, urinalysis, virus/bacteria test, etc.) conducted by the investigator according to the characteristics of the drug, vital signs, and electrocardiogram test.
排除标准
- •Those who have history or evidence of clinically significant blood, kidney, endocrine, respiratory, gastrointestinal, urinary, cardiovascular, liver, mental, nervous or immune diseases (excluding simple dental history such as calculus, impacted teeth, wisdom teeth, etc.)
- •Those whd have a history of gastrointestinal disease (esophageal disease such as achalasia or esophageal stricture, Crohn's disease) or surgery (excluding simple appendectomy, hernia surgery, or tooth extraction surgery) that may affect drug absorption ruler
- •A subject who shows the following values as a result of a laboratory test:
- •☞ ALT or AST > 2 times the upper limit of normal range
- •Those with a history of regular alcohol consumption exceeding 210 g/week within 6 months of screening (1 glass (250 mL) of beer (5%) = 10 g, 1 glass (50 mL) of soju (20%) = 8 g , 1 glass of wine (12%) (125 mL) = 12 g)
研究组 & 干预措施
Treatment(Experimental): JLP-1901
Group I(Peroid I-Comparator[JLP-2008], Peroid II-Treatment[JC-001], Period III-Comparator[JLP-2008], Peroid IV-Treatment[JC-001]), Group II(Peroid I-Treatment[JC-001]Comparator[JLP-2008], Peroid II-Comparator[JLP-2008], Period III-Treatment[JC-001], Peroid IV-Comparator[JLP-2008])
干预措施: JLP-1901 (Drug)
Treatment(Experimental): JLP-1901
Group I(Peroid I-Comparator[JLP-2008], Peroid II-Treatment[JC-001], Period III-Comparator[JLP-2008], Peroid IV-Treatment[JC-001]), Group II(Peroid I-Treatment[JC-001]Comparator[JLP-2008], Peroid II-Comparator[JLP-2008], Period III-Treatment[JC-001], Peroid IV-Comparator[JLP-2008])
干预措施: JC-001(active comparator) (Drug)
Control(Active Comparator): JC-001
Group I(Peroid I-Comparator[JLP-2008], Peroid II-Treatment[JC-001], Period III-Comparator[JLP-2008], Peroid IV-Treatment[JC-001]), Group II(Peroid I-Treatment[JC-001]Comparator[JLP-2008], Peroid II-Comparator[JLP-2008], Period III-Treatment[JC-001], Peroid IV-Comparator[JLP-2008])
干预措施: JLP-1901 (Drug)
Control(Active Comparator): JC-001
Group I(Peroid I-Comparator[JLP-2008], Peroid II-Treatment[JC-001], Period III-Comparator[JLP-2008], Peroid IV-Treatment[JC-001]), Group II(Peroid I-Treatment[JC-001]Comparator[JLP-2008], Peroid II-Comparator[JLP-2008], Period III-Treatment[JC-001], Peroid IV-Comparator[JLP-2008])
干预措施: JC-001(active comparator) (Drug)
结局指标
主要结局
Cmax of JLP-1901
时间窗: 24 hours
Cmax
AUC over 24H of JLP-1901
时间窗: 24 hours
AUC over 24H
次要结局
未报告次要终点