An Open-Label, Multiple-Dose Study to Assess the Steady-State Pharmacokinetics, Pharmacodynamics and Safety of Once-Daily Versus Twice-Daily Dosing With Canagliflozin in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 34
- 主要终点
- Plasma concentrations of canagliflozin
研究概览
简要总结
The purpose of this study is to evaluate the effects of canagliflozin on glucose levels in the blood and urine when taken at 2 dose levels as a once-daily or twice-daily dosing regimen in healthy adult volunteers
详细描述
This is an open-label (volunteers will know the names of treatments they are 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). Patients in Cohort 1 will be randomized to receive Treatment A (one 300-mg tablet orally, by mouth [PO] once daily for 5 days) followed 10 days later by Treatment B (one 50-mg and one 100-mg tablet PO twice daily for 5 days) or Treatment B followed by Treatment A. Patients in Cohort 2 will be randomized to receive Treatment C (one 100-mg tablet PO once daily for 5 days) followed 10 days later by Treatment D (one 50-mg tablet PO twice daily for 5 days) or Treatment D followed by Treatment C.
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 45 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 lactose
- •Known allergy to canagliflozin or any of the excipients of the formulation of canagliflozin
研究组 & 干预措施
001
Canagliflozin 300 mg once daily and 150 mg twice daily Treatment A (one 300-mg tablet once daily for 5 days) followed 10 days later by Treatment B (one 50-mg and one 100-mg tablet twice daily for 5 days) or Treatment B followed by Treatment A.
干预措施: Canagliflozin 300 mg once daily and 150 mg twice daily (Drug)
002
Canagliflozin 100 mg once daily and 50 mg twice daily Treatment C (one 100-mg tablet once daily for 5 days) followed 10 days later by Treatment D (one 50-mg tablet twice daily for 5 days) or Treatment D followed by Treatment C.
干预措施: Canagliflozin 100 mg once daily and 50 mg twice daily (Drug)
结局指标
主要结局
Plasma concentrations of canagliflozin
时间窗: Up to Day 5 after the last treatment
Plasma concentrations of glucose
时间窗: Up to Day 5 after the last treatment
Urinary glucose excretion (UGE)
时间窗: Up to Day 5 after the last treatment
Renal threshold of glucose (RTG)
时间窗: Up to Day 5 after the last treatment
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 8))
- Changes in hematology laboratory parameters(Up to 10 days after last dose (last dose is given on Day 8))
- Changes in chemistry laboratory parameters(Up to 10 days after last dose (last dose is given on Day 8))