NCT04654065已完成1 期
An Open-label, Single-dose Clinical Study to Evaluate Oral Mucosa Absorption of IN-C004 in Healthy 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
- 6
- 试验地点
- 1
- 主要终点
- AUCt of tegoprazan
研究概览
简要总结
To evaluate whether IN-C004 absorbs oral mucosa in healthy volunteers.
详细描述
An Open-label, Single-dose Clinical Study
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index (BMI) ≥19.0 kg/m2 and ≤27.0 kg/m2 with a body weight ≥ 45 kg at screening.
排除标准
- •History or evidence of clinically significant disease
- •History of drug/alcohol abuse
- •Participated in other studies and received investigational products within 6 months prior to the first study dose.
- •Not able to use a medically acceptable contraceptive method throughout the study.
研究组 & 干预措施
IN-C004
Experimental
IN-C004
干预措施: IN-C004 (Drug)
结局指标
主要结局
AUCt of tegoprazan
时间窗: pre-dose(0 hour), 0.08, 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2 hours
Area under the plasma concentration-time curve of tegoprazan
Cmax of tegoprazan
时间窗: pre-dose(0 hour), 0.08, 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2 hours
Maximum Plasma Concentration at Steady State of tegoprazan
Tmax of tegoprazan
时间窗: pre-dose(0 hour), 0.08, 0.17, 0.33, 0.5, 0.75, 1, 1.25, 1.5, 2 hours
Time to reach Cmax
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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