NCT01232036已完成1 期
A Clinical Trial to Compare the Pharmacokinetic and Pharmacodynamic Characteristics and Safety After Oral Administration of Glucophage With Those After Oral Administration of HL-018 in Healthy Male Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Pharmacokinetics (AUClast and Cmax)
研究概览
简要总结
This study is designed to to compare the pharmacokinetic and pharmacodynamic characteristics and safety after oral administration of Glucophage with those after oral administration of HL-018 in healthy male volunteers
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Adult males aged 19 to 50 years at screening.
- •No significant congenital/chronic disease. No symptoms in physical examination.
- •Appropriate subjects as determined by past medical history, laboratory tests, serology and urinalysis.
- •Be able to understand the objective, method of the study, the characteristics of investigational drug, and comply with the requirement of the study. Subject must provide written informed consent prior to study participation.
排除标准
- •History or presence of liver, kidney, or nervous system disease, respiratory disorders, endocrinological disorders, hemato-oncologic, cardiovascular or psychiatric or cognitive disorders.
- •History of gastrointestinal disorders (bleeding, ulceration, hemorrhoids, piles) or disorders of absorption, distribution, metabolism, excretion.
- •History of known hypersensitivity to drugs including metformin.
研究组 & 干预措施
A
Active Comparator
Reference
干预措施: Glucophage 500mg (Drug)
B
Experimental
Test
干预措施: HL-018 500mg (Drug)
C
Placebo Comparator
Placebo
干预措施: No administration of Drug (Other)
结局指标
主要结局
Pharmacokinetics (AUClast and Cmax)
时间窗: 24hours
次要结局
未报告次要终点
研究者
研究点 (1)
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