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NCT01192152 · ClinicalTrials.gov registry record · Phase 1
Bioequivalence Study of the Fixed Dose Combination of 5 mg Saxagliptin/1000 mg Metformin XR (Manufactured in Mt Vernon, IN) Relative to 5 mg of Onglyza and 2 × 500 mg Glucophage XR
A Phase 1 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT01192152 is a Phase 1 study that has completed, run by AstraZeneca. The registered enrollment target is 30 participants.
The verdict
NCT01192152, a Phase 1 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study Summary
The purpose of this study is to demonstrate bioequivalence (BE) of a 5 mg saxagliptin/1000 mg metformin extended release (XR) fixed-dose combination (FDC) tablet (manufactured in Mt Vernon, Indiana) relative to a coadministered 5 mg Onglyza tablet (saxagliptin, manufactured in Mt Vernon, Indiana) and two 500 mg Glucophage XR tablets (metformin XR, manufactured in Evansville, Indiana) in the fed state in healthy subjects.
Interventions
- DRUG saxagliptin
- DRUG saxagliptin + metformin XR (FDC tablet)
- DRUG Glucophage XR
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2009-11 |
| Est. Completion | 2009-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01192152
The ClinicalTrials.gov registry entry for NCT01192152 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 30 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 3 interventions - of which saxagliptin is the first listed.
NCT01192152 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01192152 about?
NCT01192152 is a clinical study titled "Bioequivalence Study of the Fixed Dose Combination of 5 mg Saxagliptin/1000 mg Metformin XR (Manufactured in Mt Vernon, IN) Relative to 5 mg of Onglyza and 2 × 500 mg Glucophage XR". The purpose of this study is to demonstrate bioequivalence (BE) of a 5 mg saxagliptin/1000 mg metformin extended release (XR) fixed-dose combination (FDC) tablet (manufactured in Mt Vernon, Indiana) relative to a coadministered 5 mg Onglyza tablet (saxagliptin, manufactured in Mt Vernon, Indiana) an...
What is the current status of trial NCT01192152?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2009-11. Estimated completion is 2009-12.
What interventions are being tested in trial NCT01192152?
The interventions under investigation include: saxagliptin (DRUG), saxagliptin + metformin XR (FDC tablet) (DRUG), Glucophage XR (DRUG).
Who is sponsoring clinical trial NCT01192152?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
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