An Open-label, Randomised, Multicentre, Single-dose, Parallel Group Trial to Evaluate Pharmacokinetics and Pharmacodynamics of Empagliflozin in Children and Adolescents From 10 to Less Than 18 Years of Age With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 11
- 主要终点
- t1/2
研究概览
简要总结
The aim of the study is to generate pharmacokinetic and pharmacodynamic data to identify the safe-effective dose of empagliflozin in children and adolescents aged 10 to less than 18 years with type 2 diabetes mellitus.
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
- 10 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
empagliflozin medium dose
Patient to receive a medium dose of empagliflozin
干预措施: empagliflozin medium dose (Drug)
empagliflozin low dose
Patient to receive a low dose of empagliflozin
干预措施: empagliflozin low dose (Drug)
empagliflozin high dose
Patient to receive a high dose of empagliflozin
干预措施: empagliflozin high dose (Drug)
结局指标
主要结局
t1/2
时间窗: Before drug administration (-0:30 hours (h)) and 0:30h, 1:00h, 1:30h, 2:00h, 4:00h, 8:00h, 12:00 (Day 1), 24:00 (Day 2), 34:00 (Day 2), 48:00 (Day 3) after drug administration.
Terminal half-life in plasma (t1/2).
AUC0-tz
时间窗: Before drug administration (-0:30 hours (h)) and 0:30h, 1:00h, 1:30h, 2:00h, 4:00h, 8:00h, 12:00 (Day 1), 24:00 (Day 2), 34:00 (Day 2), 48:00 (Day 3) after drug administration.
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable concentration (AUC0-tz).
Cmax
时间窗: Before drug administration (-0:30 hours (h)) and 0:30h, 1:00h, 1:30h, 2:00h, 4:00h, 8:00h, 12:00 (Day 1), 24:00 (Day 2), 34:00 (Day 2), 48:00 (Day 3) after drug administration.
Maximum measured concentration in plasma (Cmax).
AUC0-inf
时间窗: Before drug administration (-0:30 hours (h)) and 0:30h, 1:00h, 1:30h, 2:00h, 4:00h, 8:00h, 12:00 (Day 1), 24:00 (Day 2), 34:00 (Day 2), 48:00 (Day 3) after drug administration.
Area under the concentration-time curve of analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf).
Tmax
时间窗: Before drug administration (-0:30 hours (h)) and 0:30h, 1:00h, 1:30h, 2:00h, 4:00h, 8:00h, 12:00 (Day 1), 24:00 (Day 2), 34:00 (Day 2), 48:00 (Day 3) after drug administration.
Maximum measured concentration in plasma (tmax).
次要结局
- Change From Baseline in Urinary Glucose Excretion (UGE) Over 24 h After Study Drug Intake(baseline and 24 hours)
- Change From Baseline in 8-point Plasma Glucose Profile Over 24 h After Study Drug Intake(baseline and 24 hours)
- Change From Baseline in Fasting Plasma Glucose (FPG) at 24 h After Study Drug Intake(baseline and 24 hours)