NCT04967014已完成1 期
A Randomized, Open-label, Multiple-Dose, Crossover Phase 1 Clinical Trial to Evaluate the Safety and Pharmacodynamic/Pharmacokinetic Characteristics After Oral Administration of HIP2101 in Healthy Adult Volunteers
Hanmi Pharmaceutical Company Limited1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2021年5月6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
- 32
- 试验地点
- 1
- 主要终点
- Duration time with integrated gastric pH>4 / 24hr
研究概览
简要总结
A Phase 1 Study to Evaluate the Safety and Pharmacodynamic/Pharmacokinetic Characteristics of HIP2101 in Healthy Volunteers
详细描述
A Randomized, Open-label, Multiple-dose, Crossover Phase 1 Clinical Trial to Evaluate the Safety and Pharmacodynamic/Pharmacokinetic Characteristics after Oral Administration of HIP2101 in Healthy Adult Volunteers
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
- •Healthy volunteers in the age between 19 and 50 years old.
- •Body mass index (BMI) in the range of 18 to 30 kg/m2 and weight 50.0kg to 90.0kg.
- •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 (Crohn's disease or Acute/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 investigational product or the same component or other drugs.
- •Aspartate aminotransferase and alanine aminotransferase exceed 2 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 6 months before the first administration or who cannot abstain from consent to post-study visit.
- •Heavy smoker (>10 cigarettes/day).
研究组 & 干预措施
Sequence B
Experimental
Period I : HIP2104 Period II : RLD2104
干预措施: RLD2101 (Drug)
Sequence A
Experimental
Period I : RLD2104 Period II : HIP2104
干预措施: HIP2101 (Drug)
Sequence A
Experimental
Period I : RLD2104 Period II : HIP2104
干预措施: RLD2101 (Drug)
Sequence B
Experimental
Period I : HIP2104 Period II : RLD2104
干预措施: HIP2101 (Drug)
结局指标
主要结局
Duration time with integrated gastric pH>4 / 24hr
时间窗: 0-24hours
次要结局
- Median 24 hr gastric pH(0-24hours)
- Percent decrease from baseline in integrated gastric acidity for 24-hour interval after dose(0-24hours)
研究者
研究点 (1)
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