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NCT00897390 · ClinicalTrials.gov registry record · Phase 1
Bioequivalence Study of Saxagliptin and Glucophage Combination Formulations in Healthy Subjects (B)
A Phase 1 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT00897390: Completed Phase 1 study, sponsored by AstraZeneca.
NCT00897390 is a Phase 1 study that has completed, run by AstraZeneca. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00897390, a Phase 1 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
To demonstrate bioequivalence of a 2.5 mg saxagliptin/1000 mg metformin (glucophage) immediate release (IR) fixed dose combination (FDC) tablet to the 2.5 mg saxagliptin tablet and 1000 mg metformin IR tablet co-administered to healthy subjects in a fasted and in a fed state.
Primary Outcome
Single-dose PK parameters of saxagliptin were derived from plasma concentration versus time data.
Interventions
- DRUG Saxagliptin
- DRUG Metformin IR (glucophage)
- DRUG Saxagliptin + Metformin IR (FDC)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2009-06 |
| Est. Completion | 2009-07 |
| Phase | Phase 1 |
What the finished NCT00897390 record still lists
NCT00897390 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 3 interventions - of which Saxagliptin is the first listed.
NCT00897390 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00897390 about?
NCT00897390 is a clinical study titled "Bioequivalence Study of Saxagliptin and Glucophage Combination Formulations in Healthy Subjects (B)". To demonstrate bioequivalence of a 2.5 mg saxagliptin/1000 mg metformin (glucophage) immediate release (IR) fixed dose combination (FDC) tablet to the 2.5 mg saxagliptin tablet and 1000 mg metformin IR tablet co-administered to healthy subjects in a fasted and in a fed state.
What is the current status of trial NCT00897390?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2009-06. Estimated completion is 2009-07.
What interventions are being tested in trial NCT00897390?
The interventions under investigation include: Saxagliptin (DRUG), Metformin IR (glucophage) (DRUG), Saxagliptin + Metformin IR (FDC) (DRUG).
Who is sponsoring clinical trial NCT00897390?
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 NCT00897390's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 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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