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Bioequivalence Study of 2.5-mg Saxagliptin and 500-mg Glucophage in Tablets and a Fixed-dose Combination Tablet in Healthy Participants

NCT01068717 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2015-05-12

Study results available
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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.

Conditions

Interventions

DRUG

Saxagliptin, 2.5 mg + Metformin, 500 mg (fasted state)

Tablets, oral, 2.5-mg saxagliptin and 500-mg metformin, once daily, 1 week

DRUG

Saxagliptin, 2.5 mg /Metformin, 500 mg FDC (fasted state)

Tablets, oral, 2.5-mg saxagliptin/500-mg metformin fixed-dose combination (FDC), once daily, 1 week

DRUG

Saxagliptin, 2.5 mg + Metformin, 500 mg (fed state)

Tablets, oral, 2.5-mg saxagliptin and 500-mg metformin, once daily, 1 week

DRUG

Saxagliptin, 2.5 mg /Metformin, 500 mg FDC (fed state)

Tablets, oral, 2.5-mg saxagliptin and 500-mg metformin FDC, once daily, 1 week

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2010-03-31
Completion
2010-03-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01068717 on ClinicalTrials.gov