NCT01095991已完成1 期
A Randomised, Open, Phase I Study in Patients With Type 2 Diabetes Mellitus Treated With Metformin to Evaluate the Effect of AZD1656 on the Pharmacokinetics of Sitagliptin and Vice Versa
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
- 12
- 试验地点
- 1
- 主要终点
- To evaluate the effect of AZD1656 on the steady-state PK of sitagliptin and vice versa by assessment of AUC0-24 and Cmax
研究概览
简要总结
The purpose of this study is to evaluate the effects of AZD1656 on Sitagliptin pharmacokinetics and vice versa in patients with Type 2 Diabetes Mellitus.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with confirmed type 2 diabetes mellitus for at least 2 months and treated with metformin.
- •Body mass index between ≥19 and ≤42 kg/m2.
排除标准
- •Intake of another investigational drug within the last 30 days prior to enrolment.
- •Clinically significant illness or clinically relevant trauma.
研究组 & 干预措施
1
Experimental
AZD1656, day 1-5, AZD1656 + Sitagliptin day 6-10, Sitagliptin day 11-15.
干预措施: AZD1656 (Drug)
1
Experimental
AZD1656, day 1-5, AZD1656 + Sitagliptin day 6-10, Sitagliptin day 11-15.
干预措施: Sitagliptin (Drug)
2
Experimental
Sitagliptin day 1-5, AZD1656 + Sitagliptin day 6-10, AZD1656 day 11-15.
干预措施: AZD1656 (Drug)
2
Experimental
Sitagliptin day 1-5, AZD1656 + Sitagliptin day 6-10, AZD1656 day 11-15.
干预措施: Sitagliptin (Drug)
结局指标
主要结局
To evaluate the effect of AZD1656 on the steady-state PK of sitagliptin and vice versa by assessment of AUC0-24 and Cmax
时间窗: Serial PK sampling will be done on Days 5, 10 and 15
次要结局
- To evaluate the effect of AZD1656 on the steady-state PK of sitagliptin and vice versa by assessment of tmax, t1/2 and CL/F(Serial PK sampling will be done on Days 5, 10 and 15)
- To evaluate the PK of the AZD1656 and its metabolite when AZD1656 is administered with and without sitagliptin by assessment of AUC0-24, Cmax, tmax and t1/2(Serial PK sampling will be done on Days 5, 10 and 15)
- To evaluate the safety of AZD1656 with and without sitagliptin by assessment of adverse events (AEs), physical examination, electrocardiogram (ECG), pulse, blood pressure (BP), weight and FPG.(Paper ECG (days 1,2,3,6,7,8,11,16), BP/pulse preentry, every residential day. Weight, physical examination preentry and follow-up. FPG on preentry, day 1,6 and 11.)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Investigate the Effect of AZD1656 on the Pharmacokinetics of Pioglitazone and Vice Versa in Type 2 Diabetes MellitusType 2 Diabetes MellitusNCT01082120AstraZeneca28
已完成
1 期
Investigate the Effect of AZD1656 on the Pharmacokinetics and Pharmacodynamics of Warfarin in Type 2 Diabetes Mellitus (T2DM) PatientsType 2 Diabetes MellitusNCT01103609AstraZeneca16
已完成
1 期
Investigate the Effect of AZD1656 on the Pharmacokinetics of Digoxin in Type 2 Diabetes Mellitus PatientsType 2 Diabetes MellitusNCT01103622AstraZeneca20
已完成
2 期
A Study of an Investigational Drug Sitagliptin for Type 2 Diabetes Mellitus (0431-044)Type 2 Diabetes MellitusNCT00127192Merck Sharp & Dohme LLC363
已完成
1 期
Sitagliptin and Pioglitazone Mechanism of Action Study in Type 2 Diabetes Mellitus (0431-061)Type 2 Diabetes Mellitus (T2DM)NCT00511108Merck Sharp & Dohme LLC211