NCT03882112已完成1 期
A Randomized, Open-label, Single Dose, Crossover Study to Investigate the Effect of Food on the Pharmacokinetics and Pharmacodynamics of HIP1601 40 mg in Healthy Volunteers
Hanmi Pharmaceutical Company Limited1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2019年4月17日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Cmax
研究概览
简要总结
Primary objective
- To evaluate food effect on the pharmacokinetics (PK) of a single oral dose of HIP1601 in healthy subjects under fed or fasting condition.
Secondary objectives
- To explore food effect on the pharmacodynamics (PD) of single oral dose of HIP1601 in healthy subjects under fed or fasting condition.
- To evaluate the safety of single oral dose of HIP1601 in healthy subjects under fed or fasting condition.
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male/Female healthy volunteers in the age between 19 and 50 years old.
- •Body mass index (BMI) in the range of 19 to 28 kg/m2 and weight 55.0kg to 90.0kg.
- •Helicobacter pylori (H. Pylori) negative.
- •After fully hearing and understanding the details of this clinical trial, Subjects who have willingness to sign of informed consent before the screening.
- •Subject who are eligible from physical examination, clinical laboratory test by investigators judgment.
排除标准
- •Gastrointestinal disorders (gastrointestinal ulcers, gastritis, stomach cramps, gastro-esophageal reflux disease, Crohn's disease or chronic pancreatitis) or gastrointestinal surgery (except for simple cecal or hernia surgery) which may affect the safety and pharmacokinetic evaluation of test drug.
- •Subjects who have a history of hypersensitivity or clinically significant hypersensitivity to esomeprazole or the same component or other drugs (aspirin, antibiotics, etc.).
- •Blood serum aspartate aminotransferase and alanine aminotransferase exceed 1.5 times the upper limit of normal range from screening laboratory results before randomization.
- •Subject who continues to drink (21 units / week, 1 unit = 10 g of pure alcohol) within a month before the screening visit or who cannot abstain during the hospital stay.
- •Heavy smoker (>10 cigarettes/day).
研究组 & 干预措施
Sequence 1
Experimental
Period 1: Fasted state + HIP1601 Period 2: Fed state + HIP1601
干预措施: HIP1601 40mg (Drug)
Sequence 2
Experimental
Period 1: Fed state + HIP1601 Period 2: Fasted state + HIP1601
干预措施: HIP1601 40mg (Drug)
结局指标
主要结局
Cmax
时间窗: Blood sampling during 24 hours after administration
Maximum observed concentration after dose
Area Under the plasma concentration versus time Curve(AUC)last
时间窗: Blood sampling during 24 hours after administration
Area under the plasma concentration versus time curve from dosing to the last quantifiable concentration
次要结局
- t1/2(Blood sampling during 24 hours after administration)
- Vd/F(Blood sampling during 24 hours after administration)
- Tmax(Blood sampling during 24 hours after administration)
- AUCinf(Blood sampling during 24 hours after administration)
- Clearance/F(Blood sampling during 24 hours after administration)
研究者
研究点 (1)
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