NCT04185805Unknown1 期
A Randomized, Open-label, Single Dose Study to Evaluate the Safety and Pharmacokinetics of DWP14012 Tablet A and DWP14012 Tablet B in Healthy Volunteers
Daewoong Pharmaceutical Co. LTD.1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2019年12月14日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- AUCt: Area under the drug concentration-time curve from time 0 to tau (dosing interval)
研究概览
简要总结
This is a randomized, open-label, single dose study to evaluate the safety and pharmacokinetics of DWP14012 tablet A and DWP14012 tablet B in healthy volunteers
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 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 adult aged between 19 and 45 at screening
- •Those whose weight is 55 kg and more and BMI is between 17.5 and 30.5 kg/m2
- •Subjects who are adequate to be subjects in this study upon judgment of the investigator after physical examination, clinical laboratory test, examination by interview, etc
排除标准
- •Subjects who have clinical significant liver, kidney, nervous system, respiratory, endocrine, hematology and oncology, cardiovascular, urinary, and mental diseases or past history
- •Subjects who have gastrointestinal diseases or past history of gastrointestinal diseases (gastrointestinal ulcer, gastritis, gastrospasm, gastroesophageal reflux, Crohn's disease etc.) that may affect safety and pharmacokinetic/pharmacodynamic evaluation of study drug, and those who have past history of gastrointestinal surgery (however, except simple appendectomy and herniotomy)
- •Subjects who showed positive result for Helicobacter pylori test
- •Subjects with serum AST (SGOT) or ALT (SGPT) level >1.5 times the upper limit of the normal range at the time of the screening examination
- •Subjects with a history of drug abuse or a positive urine screening for drug abuse
- •Subjects who have participated and taken investigational drug in any other clinical trial (including bioequivalence study) within six months prior to study drug administration
- •Subjects who have donated a unit of whole blood within two months or blood components within one month prior to study drug administration
研究组 & 干预措施
Sequence 1 (Tablet B - Tablet A)
Experimental
Period 1 : DWP14012 tablet B Period 2: DWP14012 tablet A
干预措施: DWP14012 tablet A (Drug)
Sequence 1 (Tablet B - Tablet A)
Experimental
Period 1 : DWP14012 tablet B Period 2: DWP14012 tablet A
干预措施: DWP14012 tablet B (Drug)
Sequence 2 (Tablet A - Tablet B)
Experimental
Period 1 : DWP14012 tablet A Period 2: DWP14012 tablet B
干预措施: DWP14012 tablet A (Drug)
Sequence 2 (Tablet A - Tablet B)
Experimental
Period 1 : DWP14012 tablet A Period 2: DWP14012 tablet B
干预措施: DWP14012 tablet B (Drug)
结局指标
主要结局
AUCt: Area under the drug concentration-time curve from time 0 to tau (dosing interval)
时间窗: 0 hour (pre-dose), 0.5 hour, 1 hour, 1.5 hour, 2 hour, 2.5 hour, 3 hour, 4 hour, 6 hour, 8 hour, 12 hour, 24 hour, 48 hour
each period
Cmax: Peak concentration of DWP14012
时间窗: 0 hour (pre-dose), 0.5 hour, 1 hour, 1.5 hour, 2 hour, 2.5 hour, 3 hour, 4 hour, 6 hour, 8 hour, 12 hour, 24 hour, 48 hour
each period
次要结局
- AUCinf: Area under the drug concentration-time curve from time 0 to infinity(0 hour (pre-dose), 0.5 hour, 1 hour, 1.5 hour, 2 hour, 2.5 hour, 3 hour, 4 hour, 6 hour, 8 hour, 12 hour, 24 hour, 48 hour)
- Tmax: Time of maximum concentration(0 hour (pre-dose), 0.5 hour, 1 hour, 1.5 hour, 2 hour, 2.5 hour, 3 hour, 4 hour, 6 hour, 8 hour, 12 hour, 24 hour, 48 hour)
- t1/2: Terminal elimination half-life(0 hour (pre-dose), 0.5 hour, 1 hour, 1.5 hour, 2 hour, 2.5 hour, 3 hour, 4 hour, 6 hour, 8 hour, 12 hour, 24 hour, 48 hour)
- CL/F: Apparent Clearance(0 hour (pre-dose), 0.5 hour, 1 hour, 1.5 hour, 2 hour, 2.5 hour, 3 hour, 4 hour, 6 hour, 8 hour, 12 hour, 24 hour, 48 hour)
- Vd/F: Apparent volume of distribution(0 hour (pre-dose), 0.5 hour, 1 hour, 1.5 hour, 2 hour, 2.5 hour, 3 hour, 4 hour, 6 hour, 8 hour, 12 hour, 24 hour, 48 hour)
研究者
研究点 (1)
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