drugset / Trial / NCT01525225
Study of Saxagliptin, 5-Hydroxy Saxagliptin, and Metformin Concentrations/Levels in Pediatric Subjects With T2DM
NaSingle-groupOpen-label
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
Timeline
- Start
- 2012-09
- Primary completion
- 2013-06
- Completion
- 2013-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Metformin | Small molecule | 500 mg | Oral |
| Subject | Metformin | Small molecule | 1000 mg | Oral |
| Subject | Metformin immediate release (IR) | Unknown | 1000 mg | Oral |
| Subject | SAXAGLIPTIN ANHYDROUS | Small molecule | 2.5 mg | Oral |
| Subject | SAXAGLIPTIN ANHYDROUS | Small molecule | 5 mg | Oral |