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NCT01525225 · ClinicalTrials.gov registry record · Phase 1
Study of Saxagliptin, 5-Hydroxy Saxagliptin, and Metformin Concentrations/Levels in Pediatric Subjects With T2DM
A Phase 1 study, sponsored by AstraZeneca.
- Terminated
- Registry status
- Phase 1
- Development phase
- 4
- Enrollment target
NCT01525225 is a Phase 1 study that was terminated before completion, run by AstraZeneca. The registered enrollment target is 4 participants.
The verdict
NCT01525225, a Phase 1 study, was terminated before completion, sponsored by AstraZeneca.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 4 participants
- Enrollment target
Study 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
Interventions
- DRUG Saxagliptin
- DRUG Metformin XR
- DRUG Metformin IR
- DRUG Metformin immediate release (IR)
- DRUG Saxagliptin/Metformin XR FDC
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2012-09 |
| Est. Completion | 2013-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01525225
The ClinicalTrials.gov registry entry for NCT01525225 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 4 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Saxagliptin is the first listed.
NCT01525225 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01525225 about?
NCT01525225 is a clinical study titled "Study of Saxagliptin, 5-Hydroxy Saxagliptin, and Metformin Concentrations/Levels in Pediatric Subjects With T2DM". 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 Saxaglipt...
What is the current status of trial NCT01525225?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 4 participants. The study started on 2012-09. Estimated completion is 2013-06.
What interventions are being tested in trial NCT01525225?
The interventions under investigation include: Saxagliptin (DRUG), Metformin XR (DRUG), Metformin IR (DRUG), Metformin immediate release (IR) (DRUG), Saxagliptin/Metformin XR FDC (DRUG).
Who is sponsoring clinical trial NCT01525225?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
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