NCT02373046已完成1 期
A Phase 1, Randomized, Single-center, Open-label, 2-sequence, 2-period, Single-dose Crossover Study to Evaluate Bioequivalence (Pharmacokinetics) and to Compare Total 24-hour Urinary Glucose Excretion (Pharmacodynamics) When 400 mg LX4211 is Administered as a Single 400-mg Tablet and 2 × 200-mg Tablets in Healthy Male and Female 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
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- AUC
研究概览
简要总结
This is a randomized, single-center, open-label, 2-sequence, 2-period, single-dose, crossover study to assess the bioequivalence and the total 24-hour urinary glucose excretion (UGE) of 400 mg LX4211 administered as a single 400-mg tablet compared to 2 × 200-mg tablets in healthy subjects under fasted conditions.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult subjects ≥18 to ≤55 years of age
- •Willing and able to provide written informed consent
排除标准
- •Presence of clinically significant physical, laboratory, or ECG findings that, in the opinion of the Investigator and/or Sponsor, may interfere with any aspect of study conduct or interpretation of results
- •Existence of any surgical or medical condition that might interfere with the absorption, distribution, metabolism, or excretion of LX4211
- •History of renal disease, or significantly abnormal kidney function test at Screening
- •History of hepatic disease, or significantly abnormal liver function tests at Screening
- •History of any clinically relevant psychiatric, renal, hepatic, pancreatic, endocrine, cardiovascular, neurological, hematological, or GI abnormality
研究组 & 干预措施
Treatment A
Experimental
1 × 400-mg LX4211 tablet (fasted conditions)
干预措施: LX4211 (Drug)
Treatment B
Experimental
2 × 200-mg LX4211 tablets (fasted conditions)
干预措施: LX4211 (Drug)
结局指标
主要结局
AUC
时间窗: Days 1 to 5, Days 9 to 13
Urinary Glucose Excretion (UGE)
时间窗: Day 1, Day 9
次要结局
- # of Adverse Events(Day 1-Day 14)
研究者
研究点 (1)
Loading locations...
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