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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: Completed Phase 1 study, sponsored by AstraZeneca.
NCT01068717 is a Phase 1 study that has completed, run by AstraZeneca. The registered enrollment target is 27 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT01068717 record still lists
NCT01068717 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% lower).
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 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01068717's enrollment target sits among peer trials
27 1463rd of 2000 higher than 519 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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