NCT00817505已完成1 期
A Randomized, Open, Single-Dose, Single-Centre, Cross-over, Phase I Study in Type 1 Diabetes Mellitus Patients to Estimate the Extent and Rate of Absorption of AZD1656 After Administration of a Tablet Formulation in the Fasting State and Just Before Food in Comparison With an Oral Suspension of AZD1
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
- 11
- 试验地点
- 1
- 主要终点
- Pharmacokinetic variables ( Area under the plasma concentration vs. time curve (AUC), maximum plasma concentration (Cmax), time to reach maximum plasma concentration (tmax), terminal elimination half-life (t½) and apparent oral clearance (CL/F)
研究概览
简要总结
To evaluate the bioavailability of a tablet of AZD1656.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, type I diabetes patients, female with non child-bearing potential.
- •Treated with insulin for more than 3 years. Well controlled HbA1c.
- •Have a body mass index (BMI) ≥19 and ≤35
排除标准
- •Clinically significant illness except type I diabetes, or clinically relevant trauma, as judged by the investigator, within 2 weeks before the first administration of the investigational product
- •Daily use of nicotine containing substances.
研究组 & 干预措施
3
Active Comparator
AZD1656 tablet
干预措施: AZD1656 (Drug)
1
Active Comparator
AZD1656 tablet + food
干预措施: AZD1656 (Drug)
2
Active Comparator
AZD1656 susp. without food
干预措施: AZD1656 (Drug)
结局指标
主要结局
Pharmacokinetic variables ( Area under the plasma concentration vs. time curve (AUC), maximum plasma concentration (Cmax), time to reach maximum plasma concentration (tmax), terminal elimination half-life (t½) and apparent oral clearance (CL/F)
时间窗: Blood samples taken up to 72 hours
次要结局
- Pharmacodynamic variables (Plasma glucose)(Taken repeatedly during treatment periods)
- Safety Variables (AEs, BP, pulse, electrocardiogram (ECG), hypoglycaemic symptoms and laboratory variables)(Taken during treatment periods)
研究者
研究点 (1)
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