NCT05149274已完成1 期
A Randomized, Open-label Study to Evaluate the Pharmacokinetics and Safety of DWP14012 Tablet A and Compare Those of DWP14012 Tablet B in Healthy Subjects
Daewoong Pharmaceutical Co. LTD.1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2021年10月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- (part 2) AUC last of DWP14012
研究概览
简要总结
The pharmacokinetics (PK) and safety of oral DWP14012 tablet A will be evaluated and compared with those of DWP14012 tablet B 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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults >=19years and <=45 years of age
- •BMI >=17.5 kg/m2 and <30.5kg/m2, and body weight >= 55kg for male and >= 45kg for femlae
- •subjects with no abnormal symptoms or findings based on physical examinations
- •subjects determined eligible based on the results of lab tests
- •subjects who agree to participate
排除标准
- •Subjects with medical history that can not be participated
- •Subjects with results of lab tests performed at screening which meet any of the following :
- •ALT or AST > 1.5 times the upper limit of normal
- •Diagnosis of Helicobacter pylori (H. pylori) positive result
- •subject who is allergic to IP
- •subject with history of serious alcohol or drug abuse within 1 year prior to screening.
研究组 & 干预措施
Part1
Active Comparator
DWP14012 Tablet A : single/multiple dose, 1 group, 2 period study
干预措施: DWP14012 Tablet A (Drug)
Part2
Active Comparator
DWP14012 Tablet A 4T vs DWP14012 Tablet B 1T
干预措施: DWP14012 Tablet A (Drug)
Part2
Active Comparator
DWP14012 Tablet A 4T vs DWP14012 Tablet B 1T
干预措施: DWP14012 Tablet B (Drug)
结局指标
主要结局
(part 2) AUC last of DWP14012
时间窗: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours after dosing
(part 2) Cmax of DWP14012
时间窗: 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours after dosing
次要结局
- (part 1- period 2) AUC last of DWP14012(0 hours (pre-dose) on Day 5; 12 hours (pre-dose) on Day 7; 0 hours (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 (pre-dose), 12.5, 13, 13.5, 14, 14.5, 15, 16, 18, 20, 24, and 48 hours after dosing on Day 8)
- (part 1-period 1) AUC last of DWP14012(0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours)
- (part 1-period 1) Cmax of DWP14012(0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours)
- (Part 2) AUC inf of DWP14012(0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours after dosing)
- (Part 2) Tmax of DWP14012(0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours after dosing)
- (part 1- period 2) Cmax of DWP14012(0 hours (pre-dose) on Day 5; 12 hours (pre-dose) on Day 7; 0 hours (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 (pre-dose), 12.5, 13, 13.5, 14, 14.5, 15, 16, 18, 20, 24, and 48 hours after dosing on Day 8)
- (Part 2) t1/2 of DWP14012(0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, and 48 hours after dosing)
研究者
研究点 (1)
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