An Exploratory Clinical Trial to Evaluate and Compare Safety and Pharmacokinetic Characteristics After Administration of the DWJ1439, DWJ1464, DWC202108 or DWC202109 in Healthy Adult Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Baseline corrected/uncorrected total ursodeoxycholic acid의 Cmax
研究概览
简要总结
This study aims to Evaluate and Compare Safety and Pharmacokinetic Characteristics after Administration of the DWJ1439, DWJ1464, DWC202108 or DWC202109 in Healthy Adult Volunteers.
详细描述
The purpose of this study is to explore the differences in pharmacokinetics and safety characteristics between Test Drugs(DWJ1439, DWJ1464) and that of Reference Drugs(DWC202108, DWC202109) in healthy adults with fasting state: Randomized, open-label, oral, single-dose, four-treatment, three-period, non-replicated 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
- •Healthy adult volunteers aged 19 years old to under
- •BMI 18.0≥ and ≤30 kg/m² with body mass ≥50 kg
- •Those who have no congenital or chronic disease requiring treatment and have no pathological symptoms or findings as a result of medical examination.
- •Those who have no clinically significant abnormalities in general physical examination, laboratory assessments and 12-lead electrocardiogram (ECG).
- •Those who understand the requirements of the study and sign a written informed consent, and also accept all the restrictions imposed during the course of the study.
排除标准
- •Known history or presence of any clinically significant medical condition. Participation in a clinical drug study or bioequivalence study 6 months prior to the present study.
- •Refusal to abstain from smoking or consumption of tobacco products 72 hours before drug administration and during each study period.
- •Refusal to abstain from caffeine or grapefruit containing food or drinks for 72 hours before drug administration and during each study period.
- •Refusal to abstain from strenuous activities for 72 hours before drug administration and post-study visit, before and during each study period.
研究组 & 干预措施
Treatment A
P1: DWJ1439(ursodeoxycholic acid) 100mg, P2: DWC202108(usrodeoxycholic acid) 250mg, P3: DWJ1464(ursodeoxycholic acid) 100mg
干预措施: Ursodeoxycholic Acid 250 Mg Oral Tablet (Drug)
Treatment B
P1: DWC202108(usrodeoxycholic acid) 250mg, P2: DWJ1439(ursodeoxycholic acid) 100mg, P3: DWC202109(ursodeoxycholic acid) 250mg
干预措施: Ursodeoxycholic Acid 250 Mg Oral Tablet (Drug)
Treatment C
P1: DWJ1464(ursodeoxycholic acid) 100mg, P2: DWC202109(ursodeoxycholic acid) 250mg, P3: DWJ1439(ursodeoxycholic acid) 100mg
干预措施: Ursodeoxycholic Acid 250 Mg Oral Tablet (Drug)
Treatment D
P1: DWC202109(ursodeoxycholic acid) 250mg, P2: DWJ1464(ursodeoxycholic acid) 100mg, P3: DWC202108(usrodeoxycholic acid) 250mg
干预措施: Ursodeoxycholic Acid 250 Mg Oral Tablet (Drug)
结局指标
主要结局
Baseline corrected/uncorrected total ursodeoxycholic acid의 Cmax
时间窗: -48 - 72hours
Baseline corrected/uncorrected total ursodeoxycholic acid의 Cmax
Baseline corrected/uncorrected ursodeoxycholic acid의 Cmax
时间窗: -48 - 72hours
Baseline corrected/uncorrected ursodeoxycholic acid의 Cmax
Baseline corrected/uncorrected ursodeoxycholic acid AUC0-t
时间窗: -48 - 72hours
Baseline corrected/uncorrected ursodeoxycholic acid의 AUC0-t
Baseline corrected/uncorrected total ursodeoxycholic acid의 AUC0-t
时间窗: -48 - 72hours
Baseline corrected/uncorrected total ursodeoxycholic acid의 AUC0-t
次要结局
未报告次要终点