Investigation of the Effect of Food on the Bioavailability of a 25 mg Empagliflozin Tablet and Assessment of Dose Proportionality Between 10 mg and 25 mg Empagliflozin Tablets in an Open, Randomised, Single Dose, Three-period Cross-over Study in Healthy Male and Female Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Maximum Measured Concentration (Cmax)
研究概览
简要总结
Investigation of food effect on the bioavailability of a 25 mg empagliflozin tablet and assessment of dose proportionality between 10 mg and 25 mg empagliflozin tablets under fasting 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Treatment A
high dose of empagliflozin after overnight fasting for at least 10 h
干预措施: Empagliflozin (Drug)
Treatment B
high dose of empagliflozin after a standardised high fat breakfast
干预措施: Empagliflozin (Drug)
Treatment C
low dose empagliflozin after overnight fasting for at least 10 h
干预措施: Empagliflozin (Drug)
结局指标
主要结局
Maximum Measured Concentration (Cmax)
时间窗: 1 hour (h) before study drug and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration
Maximum measured concentration of empagloflozin (empa) in plasma, per period. The Measured Values show intra-arm variabilities, whereas the statistical analyses show inter-arm variabilities.
Area Under the Curve 0 to Infinity (AUC0-∞)
时间窗: 1 hour (h) before study drug and 20 minutes (min), 40min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after drug administration
Area under the concentration-time curve of empagliflozin (empa) in plasma over the time interval from 0 hours extrapolated to infinity (AUC0-∞). The Measured Values show intra-arm variabilities, whereas the statistical analyses show inter-arm variabilities.
次要结局
- Clinically Relevant Abnormalities for Physical Examination, Vital Signs, ECG, Clinical Laboratory Tests and Assessment of Tolerability by the Investigator.(Screening until end of trial, average of 45 days)