NCT01096940已完成1 期
A Randomized, Open-label, 3-way Crossover Phase I Study in Type 2 Diabetes Mellitus Patients Treated With Metformin to Evaluate the Pharmacokinetics and Pharmacodynamics of Simvastatin During Coadministration With AZD1656 and to Evaluate the Pharmacokinetics of AZD1656 During Coadministration With Simvastatin
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
- AstraZeneca
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- To evaluate the effect of AZD1656 on the steady state pharmacokinetics of simvastatin (including simvastatin acid) and vice versa by assessment of AUC(0-24) and Cmax.
研究概览
简要总结
To assess the pharmacokinetics of AZD1656 during coadministration with Simvastatin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a clinical diagnosis of T2DM for at least 1 year, treated with any metformin or metformin with one other oral anti-diabetic drug (OAD)
- •Body mass index between greater than or equal to 19 and less than or equal to 42 kg/m2
- •HbA1c greater than 6.5% at enrollment
排除标准
- •Clinically significant illness or clinically relevant trauma, as judged by the Investigator, within 2 weeks before the first administration of the IP
- •Significant cardiovascular event within the last 6 months prior to enrollment (eg, myocardial infarction/acute coronary syndrome, revascularisation procedure, stroke or transient ischaemic attack) or heart failure New York Heart Association (NYHA) class III-IV
研究组 & 干预措施
1
Experimental
AZD1656
干预措施: AZD1656 (Drug)
2
Experimental
Simvastatin
干预措施: simvastatin (Drug)
3
Experimental
AZD1656 + simvastatin
干预措施: AZD1656 (Drug)
3
Experimental
AZD1656 + simvastatin
干预措施: simvastatin (Drug)
结局指标
主要结局
To evaluate the effect of AZD1656 on the steady state pharmacokinetics of simvastatin (including simvastatin acid) and vice versa by assessment of AUC(0-24) and Cmax.
时间窗: Frequent blood samples for PK analysis will be drawn during 24 hours post morning dose on day 4 in each treatment period (1-3)
次要结局
- To evaluate the effect of AZD1656 on the steady state pharmacokinetics of simvastatin and simvastatin acid and vice versa by assessment of tmax, t1/2 and CL/F (only for AZD1656)(Frequent serial blood samples will be drawn during 24 hours post morning dose on Day 4 in each treatment period (1-3))
- To evaluate the steady state pharmacokinetics of the AZD1656 metabolite when AZD1656 is administered with and without simvastatin, by assessment of AUC(0-24), Cmax and tmax.(Frequent serial blood samples will be drawn during 24 hours post morning dose on Day 4 in each treatment period (1-3))
- To evaluate the effect of AZD1656 on the pharmacodynamics of simvastatin by assessment of AUC(0-t) and Cmax of active 3-hydroxy-3-methyl-glutaryl-CoA reductase inhibitors.(Frequent serial blood samples will be drawn during 24 hours post morning dose on Day 4 in each treatment period (1-3))
- To evaluate the safety and tolerability of AZD1656 alone and in combination with simvastatin by assessments of adverse events, laboratory variables, electrocardiogram, blood pressure, pulse, results of physical examination, and weight.(At pre entry, during the study days,)
研究者
研究点 (1)
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