A Randomized, Open-label, Single-dose, Replicate Crossover Study to Compare the Pharmacokinetics and Safety in Healthy Adult Volunteers Following Oral Administration of JLP-2002
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Cmax of JLP-2002
研究概览
简要总结
A randomized, open-label, single-dose, replicate crossover study to compare the pharmacokinetics and safety in healthy adult volunteers following oral administration of JLP-2002
详细描述
A randomized, open-label, single-dose, replicate crossover study
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Those who are 19 years of age or older and 55 years of age
- •BMI 18.5 ~ 27.5 kg/m2
- •Those who voluntarily agrees in writing after hearing a sufficient explanation of the purpose and procedure of the clinical trial
排除标准
- •Those with clinically significant diseases or a history of liver, kidney, cardiovascular system, endocrine system, musculoskeletal system, respiratory system, neuropsychiatric system, blood/oncology system, etc.
- •Those with a history of gastrointestinal diseases or surgery that may affect the absorption of drugs
- •Those who donated whole blood within 60 days from the date of eligibility assessment, or who donated component blood within 30 days
- •Those who do not have a medically recognized contraceptive intention or plan to provide sperm from the screening date to 4 weeks from the last administration of the investigational drug
- •Those whose blood AST, ALT, or GGT levels in the screening test exceeded 3 times the upper limit of the reference range
- •Those who showed clinically significant results in the hepatitis B test, hepatitis C test, HIV test, and syphilis test
- •In the case of women, those who do not show a negative response on the pregnancy test
- •Those who judged that the investigator is not suitable for participation in clinical trials, such as showing clinically significant results in other screening tests
研究组 & 干预措施
Group I
Period I- comparator / Period II- comparator / Period III-JLP-2002
干预措施: JLP-2002 (Drug)
Group I
Period I- comparator / Period II- comparator / Period III-JLP-2002
干预措施: Comparator (Drug)
Group II
Period I- comparator / Period II- -JLP-2002 / Period III- comparator
干预措施: JLP-2002 (Drug)
Group II
Period I- comparator / Period II- -JLP-2002 / Period III- comparator
干预措施: Comparator (Drug)
Group III
Period I- JLP-2002/ Period II- comparator / Period III- comparator
干预措施: JLP-2002 (Drug)
Group III
Period I- JLP-2002/ Period II- comparator / Period III- comparator
干预措施: Comparator (Drug)
结局指标
主要结局
Cmax of JLP-2002
时间窗: Time Frame: 192 hours
AUClast of JLP-2002
时间窗: Time Frame: 192 hours
次要结局
未报告次要终点