NCT01103622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 of Digoxin 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
- 20
- 试验地点
- 1
- 主要终点
- evaluate the pharmacokinetics of digoxin after a single dose when administered alone and in combination with AZD1656 at steady state, by assessment of AUC and Cmax of digoxin
研究概览
简要总结
The purpose of this study is to determine whether AZD1656 will affect the pharmacokinetics (PK) of digoxin in type 2 diabetes mellitus (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
- •Patients with confirmed type 2 diabetes for at least 1 year and treated with metformin as a single treatment or in combination with one other oral anti diabetic for at least 2 months prior to screening.
- •Body mass index between ≥19 and ≤42 kg/m
- •Haemoglobin (Hb) A1c ≥6.5% and ≤9.5% at enrolment.
排除标准
- •History of cardiovascular disease, eg, left ventricular hypertrophy, uncontrolled hypertension, paroxysmal or persistent cardiac arrhythmia or ischemic heart disease.
- •Systolic blood pressure >160 mmHg or diastolic blood pressure >95 mmHg at screening
- •Use of amiodarone within 3 months prior to screening and the use of potent CYP450 inhibitors
研究组 & 干预措施
1
Experimental
twice daily Day 1 to Day 7; digoxin on day 4
干预措施: AZD1656 (Drug)
1
Experimental
twice daily Day 1 to Day 7; digoxin on day 4
干预措施: Digoxin (Drug)
2
Placebo Comparator
twice daily Day 1 to Day 7; digoxin on day 4.
干预措施: Digoxin (Drug)
2
Placebo Comparator
twice daily Day 1 to Day 7; digoxin on day 4.
干预措施: Placebo (Drug)
结局指标
主要结局
evaluate the pharmacokinetics of digoxin after a single dose when administered alone and in combination with AZD1656 at steady state, by assessment of AUC and Cmax of digoxin
时间窗: Serial PK blood samples will be taken on days 4-8 during the treatment periods
次要结局
- evaluate the safety of AZD1656 in combination with digoxin 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.)
- describe the pharmacokinetics of digoxin when administered alone or in combination with AZD1656 by assessment of tmax and t1/2.(Serial PK blood samples will be taken on days 4-8 during the treatment periods)
- describe the pharmacokinetics of AZD1656 and its metabolite during concomitant digoxin administration by assessment of AUC(0-24), Cmax, Ctrough, tmax, t1/2 and CL/F (AZD1656 only).(Serial PK blood samples will be taken on days 4-8 during the treatment periods)
研究者
研究点 (1)
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