A Single-Dose, Open-Label, Randomized, 2-Way Crossover Pivotal Study to Assess the Bioequivalence of 2 Fixed Dose Combination Tablets of Canagliflozin and Metformin Immediate Release (IR) (150 mg/850 mg) With Respect to the Individual Components of Canagl
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 64
- 主要终点
- Canagliflozin plasma concentrations
研究概览
简要总结
The purpose of this study is to evaluate the bioequivalence of fixed dose combination (FDC) tablets of canagliflozin and metformin immediate release (IR) in comparison with the individual components of canagliflozin and metformin IR.
详细描述
This is an open-label (identity of study drug will be known to volunteer and study staff), single-center study to evaluate the bioequivalence of canagliflozin and metformin IR when administered orally (by mouth) as individual components (ie, separate tablets of canagliflozin and metformin IR) (Treatment A) and when administered as fixed-dose combination (FDC) tablets (ie, canagliflozin and metformin IR contained in the same tablet) (Treatment B). Healthy volunteers participating in the study will be randomly (by chance) assigned to receive Treatment A followed by Treatment B or Treatment B followed by Treatment A with a period of approximately 15 days between treatments.
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 18.5 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 (canagliflozin and metformin IR individual tablets) / B (canagliflozin/metformin IR FDC tablets) (Drug)
Treatment Sequence BA
干预措施: B (canagliflozin/metformin IR FDC tablets / A (canagliflozin and metformin IR individual tablets) (Drug)
结局指标
主要结局
Canagliflozin plasma concentrations
时间窗: At 15 time points up to 72 hours
Metformin plasma concentrations
时间窗: At 13 time points up to 24 hours
次要结局
- Adverse events(Up to approxmately 23 days)
- Clinical laboratory tests(Up to approxmately 23 days)
- Vital signs(Up to approximately 23 days)