NCT03864432已完成1 期
An Ascending Dose, Single/Multiple Dosing, Food Effect Clinical Trial to Evaluate Pharmacokinetics, Safety and Tolerability in Healthy Subjects After Oral Administration of Gemigliptin (Phase I)
LG Chem1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2019年7月2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
- 48
- 试验地点
- 1
- 主要终点
- AUClast of Gemigliptin
研究概览
简要总结
To determine the pharmacokinetic properties, safety and tolerability of single/multiple oral administration of Gemigliptin and Food effect in healthy Chinese subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female subjects (aged 19~45 years at the time of screening)
- •Subjects weighing between 50kg (inclusive) and 90kg (exclusive), and having a body mass index (BMI) of 17.1～25.8 (inclusive of limits).
- •Subjects with a fasting plasma glucose (FPG) of 70～110mg/dL (inclusive of limits) at the time of screening
- •Subjects who are willing to participate in the entire study cycle and comply with the study protocol (including contraception). Subjects who can sign the written Informed Consent Form after being informed of the study procedures.
排除标准
- •Those with a history of allergies including drug allergies (aspirin, antibiotics, etc.), or other clinically significant allergies.
- •Those with diseases of the liver (including carriers of hepatitis virus), kidney, respiratory system, endocrine system, nervous system or immune system. Those with a medical history of hematology/oncology, psychiatry or cardiovascular diseases.
- •Those with a medical history of gastrointestinal diseases (ulcers, Crohn's disease, etc.) or surgery (excluding simple appendectomy or hernia repair), and these situations can affect the absorption of the study drug.
研究组 & 干预措施
25mg SAD
Experimental
干预措施: Gemigliptin 25mg (Drug)
50mg SAD
Experimental
干预措施: Gemigliptin 50mg (Drug)
100mg SAD
Experimental
干预措施: Gemigliptin 100mg (Drug)
50mg Multiple dosing
Experimental
干预措施: Gemiglptin 50mg multiple dose (Drug)
结局指标
主要结局
AUClast of Gemigliptin
时间窗: 0h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 5h, 6h, 8h, 12h, 16h, 24h, 36h, 48h and 72h
Cmax of Gemigliptin
时间窗: 0h, 0.5h, 1h, 1.5h, 2h, 3h, 4h, 5h, 6h, 8h, 12h, 16h, 24h, 36h, 48h and 72h
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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