Single-Dose, Open-Label, Randomized, 2-Period Crossover Study to Assess the Effect of Food Coadministration on the Pharmacokinetics of a Fixed Dose Combination Tablet of Canagliflozin and Metformin Immediate Release in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 主要终点
- Canagliflozin plasma concentrations
研究概览
简要总结
The purpose of this study is to see if the absorption and distribution of a fixed-dose Combination (FDC) tablet of canagliflozin and metformin IR is affected when taken with food by healthy volunteers.
详细描述
This is an open-label (identity of study drug will be known to volunteers and study staff), single-center study to evaluate the oral bioavailability (ie, absorption and distribution within the body) and pharmacokinetics (blood levels) of a single dose of 1 fixed-dose combination (FDC) tablet of canagliflozin and metformin IR (abbreviated as 1 CANA/MET IR FDC tablet) when taken by healthy volunteers without food (in a fasting state) or with food (in a fed state). Healthy volunteers participating in the study will be randomly (by chance) assigned to receive Treatment A (1 CANA/MET IR FDC tablet taken by healthy volunteers in a fasting state) followed approximately 14 days later by Treatment B (1 CANA/MET IR FDC tablet taken by healthy volunteers in a fed state) or Treatment B followed approximately 14 days later by Treatment A.
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
- •Body mass index (BMI) 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 medical illness, abnormal values for hematology or clinical chemistry laboratory tests, or abnormal physical examination, vital signs or 12-lead electrocardiogram (ECG) deemed to be clinically significant by the Investigator
研究组 & 干预措施
Treatment Sequence AB
干预措施: A (CANA/MET IR FDC tablet - fasting state) / B (CANA/MET IR FDC tablet - fed state) (Drug)
Treatment Sequence BA
干预措施: B (CANA/MET IR FDC tablet - fed state) / A (CANA/MET IR FDC tablet - fasting state) (Drug)
结局指标
主要结局
Canagliflozin plasma concentrations
时间窗: Up to 72 hours
Metformin plasma concentrations
时间窗: Up to 24 hours
次要结局
- Adverse events(Up to approximately 22 days)
- Clinical Laboratory Tests(Up to approximately 22 days)
- Vital Signs(Up to approximately 22 days)