NCT02125305已完成1 期
A Phase I Clinical Study to Investigate the Pharmacokinetics and Pharmacodynamics of Metformin in Elderly 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
- 12
- 试验地点
- 1
- 主要终点
- AUC(area under the plasma concentration-time curve)
研究概览
简要总结
This study aims to investigate the pharmacokinetics/pharmacodynamics metformin IR after oral administration in healthy elderly male volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 85 Years（Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Males aged 65-85 years with a body mass index (BMI) of 18-28 kg/m2
- •Good health based on complete medical history, physical examinations, vital signs, electrocardiography (ECG), and clinical laboratory evaluations including hematology (blood cell count, hemoglobin, and platelet count), liver function test (aspartate aminotransferase (AST), alanine aminotransferase (ALT), and bilirubin), serum creatinine, blood glucose and urinalysis
排除标准
- •If they had clinically relevant disorders
- •Past history of diabetes or clinical findings to suspect diabetes
- •Abnormal clinical laboratory values (i.e., platelets ≤ 75,000/mm3, hemoglobin ≤ 9 g/dL, neutrophils absolute ≤ 1000/mm3, fasting glucose > 126mg/dL, creatinine ≥ 1.5 mg/dL, or AST, ALT > 3 × upper limit of normal)
研究组 & 干预措施
Metformin
Experimental
Metformin 750mg(D1), Metformin 500mg(D2)
干预措施: Metformin (Drug)
结局指标
主要结局
AUC(area under the plasma concentration-time curve)
时间窗: Predose and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12h postdose
AUC(area under the plasma concentration-time curve), Cmax(maximum plasma concentration), t1/2
次要结局
- AUGC(total area under the serum concentration-time curve for glucose concentration)(predose and 15, 30, 45, 60, 90, 120 min oral glucose tolerance test)
研究者
Jae Yong Chung
M.D., Ph.D
Seoul National University Hospital
研究点 (1)
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