NCT04087525已完成1 期
A Randomized, Open-Label, Single-Dose, Two-way Crossover Study to Compare Pharmacokinetic Properties and Safety of HIP1701 and HGP1809 in Healthy Adults
Hanmi Pharmaceutical Company Limited1 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2018年10月23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
- 31
- 试验地点
- 1
- 主要终点
- Cmax of Vildagliptin
研究概览
简要总结
An open-label, randomized, single-dose crossover study to evaluate the pharmacokinetics and safety of HIP1701 in healthy subjects.
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
- •Age 19~55 years in healthy volunteers
- •BMI is more than 18.5 kg/m^2 , no more than 24.9 kg/m^2
- •Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing
排除标准
- •Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system
- •Subjects who judged ineligible by the investigator
研究组 & 干预措施
Sequence 1
Experimental
Period 1 : Fasted state + HIP1701, Period 2 : Fasted state + HGP1809
干预措施: HIP1701 (Drug)
Sequence 1
Experimental
Period 1 : Fasted state + HIP1701, Period 2 : Fasted state + HGP1809
干预措施: HGP1809 (Drug)
Sequence 2
Experimental
Period 1 : Fasted state + HGP1809, Period 2 : Fasted state + HIP1701
干预措施: HIP1701 (Drug)
Sequence 2
Experimental
Period 1 : Fasted state + HGP1809, Period 2 : Fasted state + HIP1701
干预措施: HGP1809 (Drug)
结局指标
主要结局
Cmax of Vildagliptin
时间窗: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24 hour
pharmacokinetic evaluation
AUClast of Vildagliptin
时间窗: pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24 hour
pharmacokinetic evaluation
次要结局
- AUCinf of Vildagliptin(pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24 hour)
- Tmax of Vildagliptin(pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24 hour)
- t1/2 of Vildagliptin(pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24 hour)
- CL/F of Vildagliptin(pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24 hour)
- Vd/F of Vildagliptin(pre-dose(0 hour), 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24 hour)
研究者
研究点 (1)
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