NCT01135446已完成1 期
Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of Ultra Low Doses of Dapagliflozin 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
- 35
- 试验地点
- 1
- 主要终点
- Total 24-hour Urinary Glucose Excretion as a Measure of Pharmacodynamic Effect
研究概览
简要总结
The purpose of this study is to evaluate the pharmacodynamics (PD), pharmacokinetics (PK), safety and tolerability following single oral doses of 0.001 mg to 2.5 mg dapagliflozin in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy men and women
- •WOCBP who are using acceptable method of contraception
- •Women who are not nursing
排除标准
- •History of GI disease
- •Any GI surgery that could impact study drug absorption
- •Glucosuria at screening or Day -2
- •Abnormal liver function tests (ALT, AST or total bilirubin > 10% above ULN)
- •History of current or recurrent UTI
- •History of Diabetes Mellitus
- •History of chronic or recurrent vulvovaginal mycotic infections
- •Estimated creatinine clearance (ClCr) < 80 mL/min using Cockroft-Gault formula
- •History of allergy to SGLT2 inhibitors or related compounds
研究组 & 干预措施
dapagliflozin (0.001 mg)
Experimental
Cohort 1
干预措施: dapagliflozin (Drug)
dapagliflozin (0.01 mg)
Experimental
Cohort 2
干预措施: dapagliflozin (Drug)
dapagliflozin (0.1 mg)
Experimental
Cohort 3
干预措施: dapagliflozin (Drug)
dapagliflozin (0.3 mg)
Experimental
Cohort 4
干预措施: dapagliflozin (Drug)
dapagliflozin (1 mg)
Experimental
Cohort 5
干预措施: dapagliflozin (Drug)
dapagliflozin (2.5 mg)
Experimental
Cohort 6
干预措施: dapagliflozin (Drug)
结局指标
主要结局
Total 24-hour Urinary Glucose Excretion as a Measure of Pharmacodynamic Effect
时间窗: 24 hours after dosing
次要结局
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability(24 hours after dosing)
- Dapagliflozin and Dapagliflozin 3-O-glucuronide (Metabolite of Dapagliflozin) Concentrations to Characterize Dapagliflozin Pharmacokinetics(2 days after dosing)
研究者
研究点 (1)
Loading locations...
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