NCT03378284已完成1 期
A Randomized, Open-label, Active-controlled, Multiple Dose Phase 1 Clinical Trial to Evaluate Safety, Tolerability, and Pharmacodynamics of Tegoprazan After Oral Administration in Healthy Male Volunteers
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
- 16
- 试验地点
- 1
- 主要终点
- Gastric pH
研究概览
简要总结
A randomized, open-label, active-controlled, multiple dose phase 1 clinical trial to evaluate safety, tolerability, and pharmacodynamics of tegoprazan after oral administration in healthy male volunteers
详细描述
- To compare the pharmacodynamics of multiple oral dose of tegoprazan versus the pharmacodynamics of multiple oral dose of comparator drug in healthy male volunteers.
- To evaluate the safety and tolerability of multiple oral dose of tegoprazan in healthy male volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
Tegoprazan(Test drug)
Experimental
Tegoprazan drug QD for 7 days
干预措施: Tegoprazan (Drug)
Active comparator drug
Active Comparator
Active comparator drug QD for 7 days
干预措施: Revaprazan (Drug)
结局指标
主要结局
Gastric pH
时间窗: up to 7 days
Gastric pH
Serum gastrin concentration
时间窗: up to 9 days
Serum gastrin concentration
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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