NCT04755985已完成1 期
A Randomized, Open Label, Multi Dose, Cross Over Design Clinical Study to Evaluate the Pharmacokinetic Pharmacodynamic Characteristics and Safety of AD-213-B and AD-2132 After Oral Administration in Healthy Adult Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- AUCtau
研究概览
简要总结
A study to compare safety, pharmacokinetics and pharmacodynamics of AD-213-B to AD-2132 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
- 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 adults over 19 years of age.
- •Weight is more than 50kg and BMI is more than 18.0 kg/m^2 , no more than 27.0 kg/m^
- •Subject who has been judged to be eligible for clinical laboratory tests and electrocardiogram tests such as serum tests, hematology tests, blood chemistry tests, and urinary tests conducted within four weeks prior to the administration of clinical trials.
- •Subjects who has heard and fully understood the detailed description of this clinical trial and have willingness to sign of informed consent in writing.
排除标准
- •A subject who has a history that can affect the absorption, distribution, metabolism, or excretion of a drug.
- •As a result of laboratory tests, the following figures: ALT or AST or total bilirubin > 1.5 times upper limit of normal range.
- •As a result of laboratory tests, the following figures: Creatinine clearance < 80mL/min.
- •Subjects who judged ineligible by the investigator.
研究组 & 干预措施
ARM 1
Experimental
Period 1 : Reference Drug(AD-2132) Period 2 : Test Drug(AD-213-B)
干预措施: AD-213-B (Drug)
ARM 1
Experimental
Period 1 : Reference Drug(AD-2132) Period 2 : Test Drug(AD-213-B)
干预措施: AD-2132 (Drug)
ARM 2
Experimental
Period 1 : Test Drug(AD-213-B) Period 2 : Reference Drug(AD-2132)
干预措施: AD-213-B (Drug)
ARM 2
Experimental
Period 1 : Test Drug(AD-213-B) Period 2 : Reference Drug(AD-2132)
干预措施: AD-2132 (Drug)
结局指标
主要结局
AUCtau
时间窗: From Day 1 up to Day 17
Evaluation PK after multiple dose
The change of Integrated gastric acidity(%) from baseline
时间窗: 4 times from Day -1 to Day 17
Evaluation PD after multiple dose
次要结局
- CL/F(Day 1)
- Cmax(Day 1)
- AUClast(Day 1)
- Tmax(Day 1)
- CLss/F(Day 1 up to Day 17)
- Vdss/F(Day 1 up to Day 17)
- The change of Integrated gastric acidity(mmol∙hr/L) from baseline(4 times from Day -1 to Day 17)
- Percentage of time to maintain gastric pH 4.0 or higher(4 times from Day -1 to Day 17)
- AUCinf(Day 1 up to Day 17)
- t1/2(Day 1 up to Day 17)
- Vd/F(Day 1)
- Tmax,ss(Day 1 up to Day 17)
- Cmax,ss(Day 1 up to Day 17)
- Cmin,ss(Day 1 up to Day 17)
研究者
研究点 (1)
Loading locations...
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