NCT01103609已完成1 期
An Open-Label, Randomised, Placebo-Controlled, Two-Way Crossover, Phase I Single Centre Study in Type 2 Diabetes Mellitus Patients Treated With Metformin to Evaluate the Pharmacokinetics and Pharmacodynamics of Warfarin During Co-administration With AZD1656
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
- 16
- 试验地点
- 1
- 主要终点
- To evaluate the pharmacokinetics of warfarin after a single dose when administered alone and in combination with AZD1656 at steady state by assessment of AUC and Cmax of both enantiomers of warfarin (S- and R-warfarin).
研究概览
简要总结
The purpose of this study is to determine whether AZD1656 will affect the Pharmacokinetics and Pharmacodynamics of Warfarin in T2DM patients.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of T2DM treated with at least 1000 mg metformin as a single treatment or in combination with one other oral anti-diabetics for at least 2 months prior to screening. Doses of anti-diabetic treatment stable for at least 1 month
- •Fasting plasma glucose (FPG) at screening in the range of 6.0 to 15.0 mmol/L (108 to 270 mg/dL) and FPG in the range of 7.5 to 13.0 mmol/L (135 to 234 mg/dL) on Day 1
- •Haemoglobin (Hb) A1c >6.5% at screening
排除标准
- •Use of drugs with anticoagulant effects 3 weeks prior to first warfarin dosing
- •Use of amiodarone within 3 months prior to screening and the use of potent CYP450 inhibitors
- •Previous treatment with warfarin on clinical indication
研究组 & 干预措施
1
Experimental
twice daily on Day 1 to Day 10, with Warfarin on Day 4
干预措施: Warfarin (Drug)
1
Experimental
twice daily on Day 1 to Day 10, with Warfarin on Day 4
干预措施: AZD1656 (Drug)
2
Placebo Comparator
twice daily on Day 1 to Day 10, with Warfarin on Day 4
干预措施: Warfarin (Drug)
2
Placebo Comparator
twice daily on Day 1 to Day 10, with Warfarin on Day 4
干预措施: Placebo (Drug)
结局指标
主要结局
To evaluate the pharmacokinetics of warfarin after a single dose when administered alone and in combination with AZD1656 at steady state by assessment of AUC and Cmax of both enantiomers of warfarin (S- and R-warfarin).
时间窗: Serial PK blood samples will be taken on days 4-10 during the treatment periods
次要结局
- To evaluate the anticoagulant activity of warfarin upon co-administration with AZD1656 by assessment of prothrombin time (PT) and international normalised ratio (INR).(Serial blood samples for warfarin PD measurements will be taken on days 4-10 during the treatment periods)
- To evaluate the safety of AZD1656 in combination with warfarin by assessment of electrocardiogram, weight, pulse, blood pressure, laboratory variables (including 7-point glucose), physical examination and adverse events(Safety assessments will be monitored throughout the study, from screening visit until follow up visit.)
- To describe the pharmacokinetics of AZD1656 and its metabolite during concomitant warfarin administration by assessment of AUC0-24, Cmax, Ctrough, tmax, t1/2 and CL/F (AZD1656 only).(Serial PK blood samples will be taken on days 4-10 during the treatment periods)
研究者
研究点 (1)
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