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NCT01068717 · ClinicalTrials.gov registry record · Phase 1
Bioequivalence Study of 2.5-mg Saxagliptin and 500-mg Glucophage in Tablets and a Fixed-dose Combination Tablet in Healthy Participants
A Phase 1 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 1
- Development phase
- 27
- Enrollment target
NCT01068717 is a Phase 1 study that has completed, run by AstraZeneca. The registered enrollment target is 27 participants.
The verdict
NCT01068717, a Phase 1 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 27 participants
- Enrollment target
Study Summary
To demonstrate the bioequivalence of a 2.5-mg saxagliptin/500-mg metformin fixed-dose combination (FDC) tablet to that of 2.5-mg saxagliptin (Onglyza) and 500-mg metformin (Glucophage, marketed in Canada by Sanofi-Aventis) tablets coadministered to healthy participants in the fasted and fed states.
Interventions
- DRUG Saxagliptin, 2.5 mg + Metformin, 500 mg (fasted state)
- DRUG Saxagliptin, 2.5 mg /Metformin, 500 mg FDC (fasted state)
- DRUG Saxagliptin, 2.5 mg + Metformin, 500 mg (fed state)
- DRUG Saxagliptin, 2.5 mg /Metformin, 500 mg FDC (fed state)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2010-03 |
| Est. Completion | 2010-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01068717
The ClinicalTrials.gov registry entry for NCT01068717 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 27 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 4 interventions - of which Saxagliptin, 2.5 mg + Metformin, 500 mg (fasted state) is the first listed.
NCT01068717 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01068717 about?
NCT01068717 is a clinical study titled "Bioequivalence Study of 2.5-mg Saxagliptin and 500-mg Glucophage in Tablets and a Fixed-dose Combination Tablet in Healthy Participants". To demonstrate the bioequivalence of a 2.5-mg saxagliptin/500-mg metformin fixed-dose combination (FDC) tablet to that of 2.5-mg saxagliptin (Onglyza) and 500-mg metformin (Glucophage, marketed in Canada by Sanofi-Aventis) tablets coadministered to healthy participants in the fasted and fed states.
What is the current status of trial NCT01068717?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2010-03. Estimated completion is 2010-03.
What interventions are being tested in trial NCT01068717?
The interventions under investigation include: Saxagliptin, 2.5 mg + Metformin, 500 mg (fasted state) (DRUG), Saxagliptin, 2.5 mg /Metformin, 500 mg FDC (fasted state) (DRUG), Saxagliptin, 2.5 mg + Metformin, 500 mg (fed state) (DRUG), Saxagliptin, 2.5 mg /Metformin, 500 mg FDC (fed state) (DRUG).
Who is sponsoring clinical trial NCT01068717?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
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