A Randomized, Open-label, Single-dose Phase 1 Clinical Trial to Compare the Effect of Timing of Food on the Pharmacokinetics and Pharmacodynamics of K-CAB (Tegoprazan) in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- AUClast of tegaprazan
研究概览
简要总结
This study aims to evaluate the food-effect of tegoprazan 50mg on the pharmacokinetics and pharmacodynamics in healthy H. pylori negative male volunteers
详细描述
Primary Outcome Measure:
- AUClast and Cmax of tegaprazan
- Gastric pH
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 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy adult males aged ≥ 19 years and ≤ 50 years
- •Body weight of ≥ 55.0 kg and ≤ 90.0 kg, with body mass index (BMI) of ≥ 18.0 kg/m2 and ≤ 27.0 kg/m2 at the time of screening
- •Helicobacter pylori negative
排除标准
- •Presence or history of clinically significant diseases
- •Presence or history of gastrointestinal disorder (gastric ulcer, GERD, Crohn's disease, etc.)
- •Hypersensitivity to drugs containing study drug or proton pump inhibitor and other drugs (aspirin, antibiotics, etc.) or history of clinically significant hypersensitivity
- •Serologic test positive
- •Abnormal obstacle to insertion and maintenance of pH meter catheter
- •History of drug abuse
- •Excessive caffeine intake or persistent alcohol intake
- •Not use of a medically acceptable method of contraception
研究组 & 干预措施
Tegoprazan 50mg under fasting condition
Treatment A: single oral administration of Tegoprazan 50mg tablet under fasting condition once a day
干预措施: Tegoprazan 50mg (Drug)
Tegoprazan 50mg before the meal
Treatment B: single oral administration of Tegoprazan 50mg tablet before the meal once a day
干预措施: Tegoprazan 50mg (Drug)
Tegoprazan 50mg after the meal
Treatment C: single oral administration of Tegoprazan 50mg tablet after the meal once a day
干预措施: Tegoprazan 50mg (Drug)
结局指标
主要结局
AUClast of tegaprazan
时间窗: Pre-dose(0 hour) and up to 48 hours in each period
Area under the plasma concentration versus time curve of tegoprazan
Cmax of tegaprazan
时间窗: Pre-dose(0 hour) and up to 48 hours in each period
Peak Plasma Concentration of tegoprazan
Gastric pH
时间窗: Pre-dose(0 hour) up to 24 hours after Investigational product administration in each period
Gastric pH
次要结局
未报告次要终点