NCT04324905已完成1 期
A Randomized, Open-label, Multiple Dose, Crossover Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of HIP1802 to HGP1705 in Healthy Volunteers
Hanmi Pharmaceutical Company Limited1 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2020年4月29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
- 49
- 试验地点
- 1
- 主要终点
- AUClast
研究概览
简要总结
A Phase 1 Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of HIP1802 to HGP1705 in Healthy Volunteers
详细描述
A Randomized, Open-label, Multiple dose, Crossover Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of HIP1802 to HGP1705 in Healthy 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 19 to 28 kg/m2 and weight 55.0kg 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 (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 investigational product or the same component or other drugs (aspirin, antibiotics, etc.).
- •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
干预措施: HIP1802 (Drug)
Sequence 1
Experimental
干预措施: HGP1705 (Drug)
Sequence 2
Experimental
干预措施: HIP1802 (Drug)
Sequence 2
Experimental
干预措施: HGP1705 (Drug)
结局指标
主要结局
AUClast
时间窗: 0-24hours
Reduced rate from baseline in 24h integrated gastric pH
时间窗: 0-24hours
次要结局
- t1/2(0-24hours)
- CL/F(0-24hours)
- Cmax(0-24hours)
- Tmax(0-24hours)
- CLss/F(0-24hours)
- Vd,ss/F(0-24hours)
- Median 24 hr gastric pH(0-24hours)
- Vd/F(0-24hours)
- Cmax,ss(0-24hours)
- t1/2,ss(0-24hours)
- Reduced rate from baseline in 24h integrated gastric pH(0-24hours)
- Cmin,ss(0-24hours)
- Duration time with integrated gastric pH>4 / 24hr(0-24hours)
- AUCtau(0-24hours)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Study to Evaluate the Safety and Pharmacodynamic/Pharmacokinetic Characteristics of HIP2101 in Healthy VolunteersHealthy Adult VolunteerNCT04967014Hanmi Pharmaceutical Company Limited32
已完成
1 期
Study to Compare the Safety, Pharmacokinetics and Pharmacodynamics of HIP2105 to RLD2104 in Healthy VolunteersHealthy VolunteerNCT04975711Hanmi Pharmaceutical Company Limited48
已完成
1 期
The Pharmacokinetic Characteristics and Safety Between HIP2001 and HGP2001 in Healthy VolunteersAtrial FibrillationNCT04764201Hanmi Pharmaceutical Company Limited50
已完成
2 期
A Phase 2 Study to Explore the Dose of HCP1803 in Patients With Essential HypertensionHypertensionNCT04959305Hanmi Pharmaceutical Company Limited245
已完成
1 期
A Clinical Study to Evaluate the Pharmacokinetics, Safety and Tolerability of HIP1502HealthyNCT04018378Korea University Anam Hospital30