A Randomized, Double-blind, Placebo-controlled, Single/Multiple-dose, Phase 1 Clinical Trial to Evaluate the Safety/Tolerability and Pharmacokinetics, and Pharmacodynamics After Intravenous DWP14012 Injection in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 主要终点
- PK of Fexuprazan
研究概览
简要总结
to evaluate the safety/tolerability and pharmacokinetics, and pharmacodynamics after intravenous DWP14012 injection in healthy participants
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult volunteers aged 19 to 50 at the time of screening tests
- •Those who weigh more than 50.0 kg, 90.0 kg or less, and have a BMI of 18.5 or more and 29.9 or less at the time of screening inspection BMI (kg/m2) = Weight (kg) / {Height (m)}2
- •In the case of female volunteers, those who are not necessarily pregnant or lactating or who are in surgical infertility (bilateral ovarian obstruction, hysterectomy, bilateral ovarian resection, etc.)
- •A person who voluntarily decides to participate after hearing and fully understanding the detailed explanation of this clinical trial and agrees in writing before a screening procedure
- •A person who is suitable for this test when judging the tester by physical examination, clinical laboratory examination, questionnaire, etc
排除标准
- •Clinically significant hepatomegaly (severe liver disorder, viral hepatitis, etc.), kidney (severe renal disorder, etc.), nervous system, immune system, respiratory system, digestive system, endocrine system, blood and tumor, cardiovascular system (heart failure, Torsades de points, etc.), urinary system, mental system (fever disorder, obsessive compulsive disorder, etc.), sexual dysfunction, etc
- •A person who has a history of gastrointestinal diseases (such as Crohn's disease, ulcers, gastritis, gastritis, gastroesophageal reflux disease, etc.) or surgery (except simple appendectomy or hernia) that may affect the safety, pharmacokinetics and pharmacodynamic evaluation of clinical medicines
- •Those with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
- •A person who has been tested positive for Helicobacter pylori
- •Those who have anatomical impairments in insertion and maintenance of the pH meter catheter etc
研究组 & 干预措施
Part1_test group
IV injection of test drugs by dose group
干预措施: Fexuprazan Injection (Drug)
Part1_placebo group
IV injection of test drugs by dose group
干预措施: Fexuprazan Injection placebo (Drug)
Part2
All Participants take IV injection of test drugs
干预措施: Fexuprazan Injection_part 2 (Drug)
Part3_test group
In the case of test group, take IV injection in the period 1 and take a tablet in the period 2
干预措施: Fexuprazan Injection_part 3 (Drug)
Part3_test group
In the case of test group, take IV injection in the period 1 and take a tablet in the period 2
干预措施: Fexuprazan tablet (Drug)
Part3_reference group
In the case of reference group, take a tablet in the period 1 and take IV injection in the period 2
干预措施: Fexuprazan Injection_part 3 (Drug)
Part3_reference group
In the case of reference group, take a tablet in the period 1 and take IV injection in the period 2
干预措施: Fexuprazan tablet (Drug)
结局指标
主要结局
PK of Fexuprazan
时间窗: 0 and 72hour
1. Blood and urinary concentrations of Fexuprazan by part
PK of metabolite
时间窗: 0 and 72hour
1. Blood and urinary concentrations of metabolite by part
PD of Fexuprazan
时间窗: up to 15days
pH monitoring
次要结局
未报告次要终点