NCT00546741已完成1 期
Pharmacokinetic Drug Interaction Study With Dapagliflozin and Metformin in Healthy Subjects
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
- 18
- 试验地点
- 1
- 主要终点
- To determine the effect of metformin on the exposure of dapagliflozin and the effect of dapagliflozin on the exposure of metformin in healthy subjects after a single dose of each treatment
研究概览
简要总结
The purpose of the study is to determine the effect of metformin on dapagliflozin exposure and the effect of dapagliflozin on metformin exposure in healthy volunteers. Additionally, the safety and tolerability of dapagliflozin will be assessed in the presence and absence of metformin in healthy volunteers
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy men and women, ages 18-45 with a body mass index of 18-32 kg/m2
排除标准
- •Unwilling to use acceptable method of birth control
- •current or recent (within 1 month) smoker
- •abnormal liver function tests
- •presence of edema
- •history of diabetes mellitus
- •history of heart failure or renal insufficiency
- •history of chronic or recurrent urinary tract infections, or vulvovaginal mycotic infections
- •history of Hepatitis C
研究组 & 干预措施
1
Experimental
干预措施: Dapagliflozin (Drug)
2
Active Comparator
干预措施: Metformin (Drug)
3
Active Comparator
干预措施: Dapagliflozin + Metformin (Drug)
结局指标
主要结局
To determine the effect of metformin on the exposure of dapagliflozin and the effect of dapagliflozin on the exposure of metformin in healthy subjects after a single dose of each treatment
时间窗: measures taken daily throughout the study
次要结局
- To assess the safety and tolerability of dapagliflozin when administered alone or with metformin after a single dose of each treatment(measures will be taken at the beginning and end of the study, as well as 1 time every 3 days (Day -1 of each study period))
研究者
研究点 (1)
Loading locations...
相似试验
尚未招募
3 期
A study on the effect of Dapagliflozin and Metformin combination on Insulin resistance and cardiovascular disease risk factors in subjects with type II diabetes mellitusCTRI/2023/10/059034S Abissha
已完成
1 期
Pharmacokinetic Drug Interaction Study With Dapagliflozin and Glimepiride in Healthy SubjectsDiabetes Mellitus, Type 2NCT00562250AstraZeneca11
进行中（未招募）
1 期
Effects of glucose-lowering interventions in pre-diabetesEUCTR2015-001552-30-DKSteno Diabetes Center A/S160
已完成
3 期
Efficacy and Safety of Dapagliflozin in Combination With Metformin in Type 2 Diabetes PatientsType 2 DiabetesNCT00660907AstraZeneca1,217
已完成
1 期
Drug-drug Interaction Study of Dapagliflozin With Voglibose in Japanese Type 2 Diabetes Mellitus PatientsType 2 Diabetes MellitusNCT01055652AstraZeneca28