Evaluation of the Pharmacokinetics of Saxagliptin, 5-Hydroxy Saxagliptin, and Metformin in Children and Adolescents Aged 10 to 17 Years With Type 2 Diabetes Mellitus Following Oral Administration of Saxagliptin and Metformin XR Fixed Dose Combination Tablet and Co-Administration of Saxagliptin and Glucophage® (Metformin) IR Tablets
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- AstraZeneca
- 入组人数
- 4
- 试验地点
- 7
- 主要终点
- Number of Participants With Adverse Events (AEs) , Serious Adverse Events (SAEs), AEs Leading to Discontinuation, Death
研究概览
简要总结
The purpose of this study is to evaluate the pharmacokinetics of Saxagliptin, 5-hydroxy Saxagliptin, and Metformin in pediatric subjects with Type 2 diabetes mellitus (T2DM) following oral administration of Saxagliptin and Metformin XR fixed dose combination tablet and co-administration of Saxagliptin and Glucophage® (Metformin) IR tablets
详细描述
The primary purpose is to assess the pharmacokinetics of Saxagliptin, 5-hydroxy Saxagliptin, and Metformin in pediatric subjects aged 10 to 17 years with T2DM following oral administration of Saxagliptin and Metformin XR fixed dose combination tablet and co-administration of Saxagliptin and Glucophage® (Metformin) IR tablets
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Clinical diagnosis of T2DM
- •Male and female subjects ages 10-17
- •Body weight ≥50 kg
- •Glycosylated hemoglobin (HbA1c) 6.5 to 10%
排除标准
- •Fasting plasma glucose (FPG) > 240 mg/dL at screening
- •Abnormal renal function
- •Active liver disease and/or significant abnormal liver function
研究组 & 干预措施
Metformin + Saxagliptin + Saxagliptin/Metformin XR FDC
干预措施: Metformin immediate release (IR) (Drug)
Metformin + Saxagliptin + Saxagliptin/Metformin XR FDC
干预措施: Saxagliptin (Drug)
Metformin + Saxagliptin + Saxagliptin/Metformin XR FDC
干预措施: Metformin IR (Drug)
Metformin + Saxagliptin + Saxagliptin/Metformin XR FDC
干预措施: Saxagliptin/Metformin XR FDC (Drug)
Metformin + Saxagliptin + Saxagliptin/Metformin XR FDC
干预措施: Metformin XR (Drug)
结局指标
主要结局
Number of Participants With Adverse Events (AEs) , Serious Adverse Events (SAEs), AEs Leading to Discontinuation, Death
时间窗: Day 1 up to Day 8, plus 30 days
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug.
次要结局
- Number of Participants With Marked Chemistry or Hematology Laboratory Abnormalities(Day 1 to Day 8)