A Randomized, Open-label, Active-controlled, Single/Multiple-dose Phase 1 Clinical Trial to Evaluate Pharmacokinetics/Pharmacodynamics and Safety/Tolerability of Tegoprazan After Oral Administration in Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- AUC(0-24h) of tegoprazan
研究概览
简要总结
A randomized, open-label, active-controlled, single/multiple-dose phase 1 clinical trial to evaluate pharmacokinetics/pharmacodynamics and safety/tolerability of tegoprazan after oral administration in healthy male subjects
详细描述
- To evaluate the pharmacokinetics and pharmacodynamics of single oral dose of tegoprazan between dose groups in healthy H. pylori negative males.
- To evaluate the pharmacokinetics and pharmacodynamics of multiple oral dose of tegoprazan under the fed state in healthy H. pylori negative males.
- To evaluate the pharmacokinetics and pharmacodynamics of single oral dose of tegoprazan in healthy H. pylori positive males.
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 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
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
Treatment A: Tegoprazan (C1)
Tegoprazan QD, oral administration
干预措施: Tegoprazan (C1) (Drug)
Treatment B: Tegoprazan (C1)
Tegoprazan QD, oral administration
干预措施: Tegoprazan (C1) (Drug)
Group 1: Tegoprazan (C2)
Tegoprazan QD, oral administration, for 7 days
干预措施: Tegoprazan (C2) (Drug)
Group 2: Tegoprazan (C2)
Tegoprazan QD, oral administration, for 7 days
干预措施: Tegoprazan (C2) (Drug)
Group 3: Esomeprazole (C2)
Esomeprazole QD, oral administration, for 7 days
干预措施: Esomeprazole (C2) (Drug)
Tegoprazan (C3)
Tegoprazan QD, oral administration
干预措施: Tegoprazan (C3) (Drug)
结局指标
主要结局
AUC(0-24h) of tegoprazan
时间窗: up to 7 days
Area Under the Curve(0-24h) of tegoprazan
Cmax of tegoprazan
时间窗: up to 7 days
Maximum Plasma Concentration of tegoprazan
Gastric pH
时间窗: up to 7 days
Gastric pH
Serum gastrin concentration
时间窗: up to 7 days
Serum gastrin concentration
次要结局
未报告次要终点