An Open-label, Randomized, Single-dose, Crossover Study to Evaluate the Pharmacokinetic Characteristics and Safety of IN-C004 in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- AUCt of tegoprazan metabolite M1
研究概览
简要总结
To evaluate the pharmacokinetic characteristics and safety of IN-C004 in healthy volunteers
详细描述
An Open-label, Randomized, Single-dose, Crossover Study
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 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.
- •AST(GOT) or ALT(GPT) > 2 X upper limit of normal at screening
- •Not able to use a medically acceptable contraceptive method throughout the study.
研究组 & 干预措施
Group 2
Group 2
干预措施: IN-C004 without water (Drug)
Group 1
Group 1
干预措施: IN-C004 with water (Drug)
Group 1
Group 1
干预措施: IN-C004 without water (Drug)
Group 1
Group 1
干预措施: K-CAB tab. with water (Drug)
Group 2
Group 2
干预措施: IN-C004 with water (Drug)
Group 2
Group 2
干预措施: K-CAB tab. with water (Drug)
Group 3
Group 3
干预措施: IN-C004 with water (Drug)
Group 3
Group 3
干预措施: IN-C004 without water (Drug)
Group 3
Group 3
干预措施: K-CAB tab. with water (Drug)
Group 4
Group 4
干预措施: IN-C004 with water (Drug)
Group 4
Group 4
干预措施: IN-C004 without water (Drug)
Group 4
Group 4
干预措施: K-CAB tab. with water (Drug)
Group 5
Group 5
干预措施: IN-C004 with water (Drug)
Group 5
Group 5
干预措施: IN-C004 without water (Drug)
Group 5
Group 5
干预措施: K-CAB tab. with water (Drug)
Group 6
Group 6
干预措施: IN-C004 with water (Drug)
Group 6
Group 6
干预措施: IN-C004 without water (Drug)
Group 6
Group 6
干预措施: K-CAB tab. with water (Drug)
结局指标
主要结局
AUCt of tegoprazan metabolite M1
时间窗: pre-dose(0 hour), 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hour
Area under the plasma concentration-time curve of tegoprazan metabolite M1
Cmax of tegoprazan metabolite M1
时间窗: pre-dose(0 hour), 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours
Maximum Plasma Concentration at Steady State of tegoprazan metabolite M1
AUCt of tegoprazan
时间窗: pre-dose(0 hour), 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours
Area under the plasma concentration-time curve of tegoprazan
Cmax of tegoprazan
时间窗: pre-dose(0 hour), 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours
Maximum Plasma Concentration at Steady State of tegoprazan
次要结局
未报告次要终点