NCT03043521已完成1 期
Phase I Study to Investigate Pharmacodynamics of CJ-12420 Compared to Dexlansoprazole With Evening Dosing
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
- 24
- 试验地点
- 1
- 主要终点
- Time pH > 4 of CJ-12420
研究概览
简要总结
The purpose of this study is to compare and evaluate impact on pharmacodynamic characteristics of CJ-12420 and dexlansoprazole with evening dosing in healthy male volunteers
详细描述
Evaluation Criteria:
- Pharmacokinetic Endpoints Cmax, tmax, AUClast of CJ-12420
- Pharmacodynamics Endpoints Time pH > 4 Time pH > 6 Integrated acidity Percent inhibition of integrated acidity Percent inhibition time gastric pH ≤ 4 Median pH
- Safety Assessments Physical examination, ECGs, vital signs (blood pressure, heart rate, body temperature), laboratory test (CBC, Chemistry, UA), and adverse events (AEs)
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
- 20 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male volunteers aged ≥20 to ≤45 years
- •Body mass Index (BMI) of 19 to 28kg/m2 ; and a total body weight ≥ 50kg
- •Medically healthy without clinically significant vital signs (blood pressure in sitting position, heart rate)
- •90 mmHg ≤ Systolic blood pressure (SBP) ≤ 140 mmHg
- •50 mmHg ≤ Diastolic blood pressure (DBP) ≤ 95 mmHg
- •45 (beats/min) ≤ Heart rate ≤ 95 (beats/min)
- •Understand restriction during the study and voluntarily consent to participate in the study
- •Consent to use the effective contraceptive methods (using abstinence, spermicide, and condom) and not to donate sperm during the study and until 30 days after completion of study
- •Non-smoker or ex-smoker who stopped smoking for at least one year
- •Negative H. pylori result in urea breath test (UBT)
排除标准
- •History of clinically significant diseases in the digestive, kidney, liver, nervous, hemato-oncologic, endocrine, respiratory, immune, psychiatric, musculoskeletal, or cardiovascular system and other diseases that may harm safety of the subject or may affect the validity of study results, in the judgment of investigator
- •History of allergy or hypersensitivity to any drugs including serious adverse events from treatments such as PPI (omeprazole, rabeprazole, lansoprazole) or P-CAB
- •History surgery that may affect absorption, distribution, metabolism, and elimination of the study drug or in such a medical condition, at the discretion of the principal investigator or sub-investigator
- •History of use of another investigational product within 90 days prior to screening visit
- •Donation of a unit of whole blood within 60 days or blood components or transfusion within 30 days prior to screening visit
- •Having special diet or changes in dietary habits within 30 days prior to screening visit
- •Use of prescription drug within 14 days or over-the-count (OTC) drug including herbal medicine within 7 days prior to screening visit
- •Alcohol > 21 units/week
- •Caffeinated drink intake > 5units/day
- •Positive on urinary drug screening test or urine nicotine test
- •Positive human immunodeficiency virus (HIV), hepatitis B, hepatitis C, or syphilis test
- •Clinically significant abnormal result of liver function (serum ALT, AST or total bilirubin levels ≥ 1.5 times the upper limit of normal (ULN))
- •Inability to tolerate pH catheter insertion
- •History of symptomatic GERD, erosive esophagitis (EE), duodenal ulcer, gastric ulcer, Barrett's esophagus, or Zollinger-Ellison Syndrome
- •Any other conditions which would have made the subject unsuitable for the study in the opinion of the investigator
研究组 & 干预措施
CJ-12420 50mg
Experimental
T1=CJ-12420 50mg QD evening (9PM)
干预措施: CJ-12420 50mg (Drug)
CJ-12420 100mg
Experimental
T2=CJ-12420 100mg QD evening (9PM)
干预措施: CJ-12420 100mg (Drug)
CJ-12420 200mg
Experimental
T3=CJ-12420 200mg QD evening (9PM)
干预措施: CJ-12420 200mg (Drug)
Dexlansopazole 60mg
Active Comparator
R=dexlansoprazole 60mg QD evening (9p.m)
干预措施: Dexlansoprazole 60 MG (Drug)
结局指标
主要结局
Time pH > 4 of CJ-12420
时间窗: 24 hours pH
intragastric pH
次要结局
- Time pH > 4 of dexlansoprazole(24 hours pH)
- Median pH > 4 of CJ-12420(24 hours pH)
- Cmax of dexlansoprazole(up to 20 hours)
- AUClast of dexlansoprazole(up to 20 hours)
- Median pH > 4 of dexlansoprazole(24 hours pH)
- Cmax of CJ-12420(up to 20 hours)
- AUClast of CJ-12420(up to 20 hours)
研究者
研究点 (1)
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