NCT01072578已完成1 期
An Open-label, Randomised, Two-period Crossover Study to Assess the Effect of Dapagliflozin on Percent Inhibition of Glucose Re-absorption When Administered Once a Day (10 mg OD) Versus Twice a Day (5 mg BID) in Healthy Male and Female Volunteers
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
- Calculation of derivation of pharmacokinetic variables
研究概览
简要总结
The primary objective of the study is to assess the effect of dapagliflozin on the amount of glucose in the blood and urine when dapagliflozin is administered once a day (10 mg) versus twice a day (5 mg every 12 hours) after five days of dosing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 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
- •Female healthy volunteers must be post-menopausal (cessation of menses >1year, be surgically sterile (documented) or have undergone hysterectomy) or be sexually abstinent from enrolment until follow-up examination
- •Have normal physical exam, vital signs ECG findings, and laboratory values
排除标准
- •Use of prescription medication for a chronic or acute medical condition within 3 weeks of randomization
- •History or presence of neurological, haematological, psychiatric, gastrointestinal, hepatic or renal disease, or other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs as determined by the Investigator
- •Previous participation in an AstraZeneca (AZ) or Bristol-Myers Squibb (BMS) dapagliflozin study
研究组 & 干预措施
1
Experimental
干预措施: Dapagliflozin (Drug)
2
Experimental
干预措施: Dapagliflozin (Drug)
结局指标
主要结局
Calculation of derivation of pharmacokinetic variables
时间窗: Up to 14 blood samples will be obtained on day 1 (with the closest interval between samples being 15 minutes), one sample on days 3 and 4, and up to 21 samples on day 5
次要结局
- Calculation of derivation of pharmacodynamic variables (inhibition of plasma glucose re-absorption, 24 hour urine glucose excretion, inhibition of rate of gut glucose absorption by measuring plasma glucose, insulin and GIP).(plasma glucose will be drawn on Day 5, creatinine will be drawn at pre-dose of Day 4 and of Day 5, glucose and insulin will be drawn on Day 5 , Day 5 for GIP, urine will be collected on Day 5 in 4-hour intervals)
- To examine the safety and tolerability of the combination of dapagliflozin and metformin(Adverse events and laboratory variables assessed throughout both 5-day treatment periods, and a follow-up visit 5-10 days later)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Effects of Dapagliflozin on Insulin Resistance and Insulin Secretion in Subjects With Type 2 DiabetesType 2 Diabetes MellitusNCT00831779AstraZeneca116
已完成
3 期
Efficacy and Safety in Patients With Type 2 Diabetes Mellitus, Cardiovascular Disease and HypertensionInadequate Glycaemic ControlHypertensionType 2 Diabetes MellitusCardiovascular DiseaseNCT01031680AstraZeneca922
已完成
不适用
Usage of Dapagliflozin in the Management of Type-2 Diabetes Mellitus: A Real World Evidence Study in Indian PatientsType 2 DiabetesNCT03071016AstraZeneca2,000
已完成
3 期
Efficacy and Safety in Patients With Type 2 Diabetes Mellitus and Cardiovascular DiseaseInadequate Glycaemic ControlType 2 Diabetes MellitusCardiovascular DiseaseNCT01042977AstraZeneca964
已完成
3 期
Dapagliflozin DPPIV Inhibitor add-on StudyType 2 DiabetesNCT00984867AstraZeneca833