NCT01426399已完成1 期
A Randomized, Open-label, Multiple Dosing, Three-way Crossover Clinical Trial to Investigate the Pharmacokinetic/Pharmacodynamic Drug-drug Interaction of LC15-0444 and Metformin After Oral Administration in Healthy Male Subjects
LG Life Sciences1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2011年8月最近更新:
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
- 30
- 试验地点
- 1
- 主要终点
- AUCτ,ss
研究概览
简要总结
The objective of the study was to investigate the drug-drug interaction between LC15-0444 and metformin by comparing the pharmacokinetic/pharmacodynamic, safety, tolerability in healthy male subjets after oral administration concomitantly and each alone.
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
- 20 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Age between 20 to 45, healthy male subjects(at screening)
- •Body weight between 55kg - 90kg, BMI between 18.0 - 27.0
- •FPG 70-125mg/dL glucose level(at screening)
- •Subject who totally understand the progress of this clinical trials, make decision by his free will, and signed a consent form to follow the progress.
排除标准
- •Subject who has past or present history of any diseases following below.(liver including hepatitis virus carrier, kidney, Neurology,immunology,pulmonary,endocrine,hematooncology,cardiology,mental disorder.)
- •Subject who had GI tract disease or(ulcer, acute or chronic pancreatitis) surgery.(appendectomy, hernioplasty are not included)
- •Subject who had drug hypersensitivity reaction.(Aspirin, antibiotics)
- •Subject who already participated in other trials in 2months
- •Subject who had whole blood donation in 2months, or component blood donation in 1months or transfusion in 1months currently.
- •Smokers.(but, if the subject did'nt smoke in 3months, can participate the trial)
研究组 & 干预措施
LC15-0444
Experimental
LC15-0444 50mg qd
干预措施: LC15-0444 (Drug)
Metformin
Experimental
Metformin 1000mg bid
干预措施: Metformin (Drug)
LC15-0444+Metformin
Experimental
LC15-0444 50mg qd +Metformin 1000mg bid
干预措施: LC15-0444+Metformin (Drug)
结局指标
主要结局
AUCτ,ss
时间窗: up to 171h30m
To confirm and evaluate the pharmacokinetic characters of main metabolites of LC15-0444
Cmax,ss
时间窗: up to 171h 30m
To confirm and evaluate the pharmacokinetic characters of main metabolites of LC15-0444
次要结局
- Vital signs(up to 171h30m)
- AUECτ,ss(up to 171h30m)
- AUEC(up to 171h30m)
研究者
研究点 (1)
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