KCT0002887招募中未知
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
- 未知
- 状态
- 招募中
- 入组人数
- 44
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 50(Year)（—）
- 性别
- Male
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
研究者
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