Conditions: Type 2 Diabetes Mellitus
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 4
Healthy volunteers: no

Brief summary:
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

Detailed description:
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

Arms:
arm 1: None

Interventions: intervention 1: Metformin immediate release (IR) intervention 2: Saxagliptin intervention 3: Metformin IR intervention 4: Saxagliptin/Metformin XR FDC intervention 5: Metformin XR
Intervention descriptions: intervention 1: Tablet, Oral, 1000 mg, twice daily, 1 day intervention 2: Tablet, Oral, 5 mg, single-dose, 1 day intervention 3: Tablet, Oral, 1000 mg, twice daily, 5 days intervention 4: Tablet, Oral, 2.5 mg Saxagliptin/1000 mg Metformin extended release (XR), Single-dose of 2 tablets. Fixed dose combination (FDC). intervention 5: Tablet, Oral, 500 mg, Single-dose of 4 tablets

Protocol document: