An Exploratory Clinical Trial to Compare and Evaluate Safety and Pharmacokinetic Characteristics After Administration of the DWJ1439, DWJ1464, DWC202003 or DWC202004 in Healthy Adult Volunteers
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- PK parameters of baseline corrected/uncorrected ursodeoxycholic acid: AUC0-t
研究概览
简要总结
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(DWC202003, DWC202004) in healthy adults.
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(DWC202003, DWC202004) 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 —（Adult, Older 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 alcohol, caffeine, or other xanthines, 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
Sequence A
7 subjects assigned to Sequence A will receive a single dose of 300mg DWJ1439 in period 1, 300mg DWC202003 in period 2 and 300mg DWJ1464 in period 3.
干预措施: DWC202003 (Drug)
Sequence A
7 subjects assigned to Sequence A will receive a single dose of 300mg DWJ1439 in period 1, 300mg DWC202003 in period 2 and 300mg DWJ1464 in period 3.
干预措施: DWJ1439 (Drug)
Sequence A
7 subjects assigned to Sequence A will receive a single dose of 300mg DWJ1439 in period 1, 300mg DWC202003 in period 2 and 300mg DWJ1464 in period 3.
干预措施: DWJ1464 (Drug)
Sequence B
7 subjects assigned to Sequence B will receive a single dose of 300mg DWJ1464 in period 1, 300mg DWC202004 in period 2 and 300mg DWC202003 in period 3.
干预措施: DWJ1464 (Drug)
Sequence B
7 subjects assigned to Sequence B will receive a single dose of 300mg DWJ1464 in period 1, 300mg DWC202004 in period 2 and 300mg DWC202003 in period 3.
干预措施: DWC202003 (Drug)
Sequence B
7 subjects assigned to Sequence B will receive a single dose of 300mg DWJ1464 in period 1, 300mg DWC202004 in period 2 and 300mg DWC202003 in period 3.
干预措施: DWC202004 (Drug)
Sequence C
7 subjects assigned to Sequence C will receive a single dose of 300mg DWC202003 in period 1, 300mg DWJ1439 in period 2 and 300mg DWC202004 in period 3.
干预措施: DWJ1439 (Drug)
Sequence C
7 subjects assigned to Sequence C will receive a single dose of 300mg DWC202003 in period 1, 300mg DWJ1439 in period 2 and 300mg DWC202004 in period 3.
干预措施: DWC202003 (Drug)
Sequence C
7 subjects assigned to Sequence C will receive a single dose of 300mg DWC202003 in period 1, 300mg DWJ1439 in period 2 and 300mg DWC202004 in period 3.
干预措施: DWC202004 (Drug)
Sequence D
7 subjects assigned to Sequence D will receive a single dose of 300mg DWC202004 in period 1, 300mg DWJ1464 in period 2 and 300mg DWJ1439 in period 3.
干预措施: DWJ1439 (Drug)
Sequence D
7 subjects assigned to Sequence D will receive a single dose of 300mg DWC202004 in period 1, 300mg DWJ1464 in period 2 and 300mg DWJ1439 in period 3.
干预措施: DWJ1464 (Drug)
Sequence D
7 subjects assigned to Sequence D will receive a single dose of 300mg DWC202004 in period 1, 300mg DWJ1464 in period 2 and 300mg DWJ1439 in period 3.
干预措施: DWC202004 (Drug)
结局指标
主要结局
PK parameters of baseline corrected/uncorrected ursodeoxycholic acid: AUC0-t
时间窗: 0 - 72 hours after dosing
Area under the plasma concentration-time curve from time 0 to time t
PK parameters of baseline corrected/uncorrected total ursodeoxycholic acid: Cmax
时间窗: 0 - 72 hours after dosing
Maximum plasma drug concentration
PK parameters of baseline corrected/uncorrected ursodeoxycholic acid: Cmax
时间窗: 0 - 72 hours after dosing
Maximum plasma drug concentration
PK parameters of baseline corrected/uncorrected total ursodeoxycholic acid: AUC0-t
时间窗: 0 - 72 hours after dosing
Area under the plasma concentration-time curve from time 0 to time t
次要结局
- PK parameters of baseline corrected/uncorrected ursodeoxycholic acid: Tmax(0 - 72 hours after dosing)
- PK parameters of baseline corrected/uncorrected total ursodeoxycholic acid: AUCinf(0 - 72 hours after dosing)
- PK parameters of baseline corrected/uncorrected total ursodeoxycholic acid: Tmax(0 - 72 hours after dosing)
- PK parameters of baseline corrected/uncorrected ursodeoxycholic acid: AUCinf(0 - 72 hours after dosing)
- PK parameters of baseline corrected/uncorrected ursodeoxycholic acid: , Cl/F(0 - 72 hours after dosing)
- PK parameters of baseline corrected/uncorrected total ursodeoxycholic acid: t1/2(0 - 72 hours after dosing)
- PK parameters of baseline corrected/uncorrected ursodeoxycholic acid: t1/2(0 - 72 hours after dosing)
- PK parameters of baseline corrected/uncorrected ursodeoxycholic acid: Vd/F(0 - 72 hours after dosing)
- PK parameters of baseline corrected/uncorrected total ursodeoxycholic acid: Cl/F(0 - 72 hours after dosing)
- PK parameters of baseline corrected/uncorrected total ursodeoxycholic acid: Vd/F(0 - 72 hours after dosing)