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NCT01068743 · ClinicalTrials.gov registry record · Phase 1

Bioequivalence Study of Fixed Dose Combination of 2.5 mg Saxagliptin/850 mg Metformin Tablet Relative to 2.5 mg Onglyza and 850 mg Glucophage Tablets Co-Administered

A Phase 1 study, sponsored by AstraZeneca.

Completed
Registry status
Phase 1
Development phase
24
Enrollment target

NCT01068743 is a Phase 1 study that has completed, run by AstraZeneca. The registered enrollment target is 24 participants.

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The verdict

NCT01068743, 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/850 mg metformin fixed dose combination (FDC) tablet relative to the 2.5 mg saxagliptin tablet and 850 mg metformin (Glucophage Marketed by Merck-Serono) tablet co-administered to healthy subjects in the fasted and fed condition.

Interventions

  • DRUG metformin
  • DRUG saxagliptin
  • DRUG saxagliptin + metformin (FDC tablet)

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2010-02
Est. Completion 2010-03
Phase Phase 1

Sponsor

AstraZeneca

1,285 total trials

What the Registry Record Tells You About NCT01068743

The ClinicalTrials.gov registry entry for NCT01068743 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 metformin is the first listed.

NCT01068743 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01068743 about?

NCT01068743 is a clinical study titled "Bioequivalence Study of Fixed Dose Combination of 2.5 mg Saxagliptin/850 mg Metformin Tablet Relative to 2.5 mg Onglyza and 850 mg Glucophage Tablets Co-Administered". To demonstrate bioequivalence of a 2.5 mg saxagliptin/850 mg metformin fixed dose combination (FDC) tablet relative to the 2.5 mg saxagliptin tablet and 850 mg metformin (Glucophage Marketed by Merck-Serono) tablet co-administered to healthy subjects in the fasted and fed condition.

What is the current status of trial NCT01068743?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2010-02. Estimated completion is 2010-03.

What interventions are being tested in trial NCT01068743?

The interventions under investigation include: metformin (DRUG), saxagliptin (DRUG), saxagliptin + metformin (FDC tablet) (DRUG).

Who is sponsoring clinical trial NCT01068743?

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.