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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 is a Phase 1 study that has completed, run by AstraZeneca. The registered enrollment target is 24 participants.

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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.

Interventions

  • DRUG Saxagliptin
  • DRUG Metformin IR (glucophage)
  • DRUG Saxagliptin + Metformin IR (FDC)

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2009-06
Est. Completion 2009-07
Phase Phase 1

Sponsor

AstraZeneca

1,285 total trials

What the Registry Record Tells You About NCT00897390

The ClinicalTrials.gov registry entry for NCT00897390 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 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.

NCT00897390 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.