An Open-Label, Randomized, Parallel-Group, Single-Center Study to Evaluate the Single and Multiple Dose Pharmacokinetic and Pharmacodynamic Characteristics of JNJ-28431754 (Canagliflozin) in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 27
- 主要终点
- Plasma concentrations of canagliflozin
研究概览
简要总结
The purpose of this study is to determine blood and urine concentrations of canagliflozin and glucose in healthy adult volunteers after administration of single and multiple doses of canagliflozin.
详细描述
This is an open-label (volunteers and study staff will know the name and dose of the treatment assigned), single-center study of canagliflozin (JNJ-28431754) in healthy adult volunteers. Canagliflozin (a sodium-glucose cotransporter 2-inhibitor) is currently under development to lower blood sugar levels in patients with Type 2 diabetes mellitus (T2DM). Healthy volunteers will take canagliflozin 50 mg, 100 mg, or 300 mg tablets, orally (by mouth), once daily on Day 1 and on Days 4 to 9. All study drug administration will occur at approximately the same time each morning with 240 mL of noncarbonated water and will be followed by a standardized breakfast within 10 minutes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Healthy volunteers with a body mass index (BMI, a measure of a person's weight in relation to height) between 18 and 30 kg/m2, inclusive, and a body weight of not less than 50 kg
排除标准
- •History of or current clinically significant medical illness as determined by the Investigator
- •History of clinically significant allergies, especially known hypersensitivity or intolerance to drugs or lactose
- •Known allergy to canagliflozin or any of the excipients of the formulation of canagliflozin
研究组 & 干预措施
001
Canagliflozin 50 mg Tablets oral 50-mg once daily on Day 1 and on Days 4 through 9.
干预措施: Canagliflozin 50 mg (Drug)
002
Canagliflozin 100 mg Tablets oral 100-mg once daily on Day 1 and on Days 4 through 9.
干预措施: Canagliflozin 100 mg (Drug)
003
Canagliflozin 300 mg Tablets oral 300-mg once daily on Day 1 and on Days 4 through 9.
干预措施: Canagliflozin 300 mg (Drug)
结局指标
主要结局
Plasma concentrations of canagliflozin
时间窗: At protocol-specified times up to Day 14
Urine concentrations of canagliflozin
时间窗: At protocol-specified times up to Day 11
Plasma glucose concentrations
时间窗: At protocol-specified times up to Day 11
Urine glucose concentrations
时间窗: At protocol-specified times up to Day 11
次要结局
- The number and type of adverse events reported(Up to 10 days after last dose" (last dose is given on Day 9))
- Changes in hematology, chemistry and urinalysis parameters(Up to 10 days after last dose" (last dose is given on Day 9))