MedTrace Logo

Bioequivalence Study of Fixed-dose Combinations and Coadministered Individual Tablets of Saxagliptin/Metformin-Brazil

NCT01365091 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2015-05-08

Study results available
· View outcomes & findings →

Summary

To demonstrate the bioequivalence of saxagliptin and metformin in a saxagliptin, 5-mg/metformin extended-release (XR), 500-mg, fixed-dose combination (FDC) tablet with saxagliptin, 5-mg and metformin, 500-mg XR tablets administered together in both the fasted and fed states. In addition, to demonstrate the bioequivalence of saxagliptin and metformin in a saxagliptin, 5-mg/metformin XR, 1000-mg, FDC tablet with saxagliptin, 5-mg and metformin, 1000-mg XR tablets administered together in both the fasted and fed states.

Conditions

Interventions

DRUG

Saxagliptin/metformin fixed-dose combination (FDC)

Tablet, oral, 5 mg/500 mg FDC, once on Day 1 only, 1 day

DRUG

Saxagliptin

Tablet, oral, 5 mg, once on Day 1 only, 1 day

DRUG

Metformin extended-release (XR)

Tablet, oral, 500 mg, once on Day 1 only, 1 day

DRUG

Saxagliptin/Metformin FDC

Tablet, Oral, 5 mg/1000 mg FDC, once on Day 1 only, 1 day

DRUG

Metformin

Tablet, oral, 1000 mg, once on Day 1 only, 1 day

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
2011-06-30
Primary Completion
2011-11-30
Completion
2011-11-30

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Drugs
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 NCT01365091 on ClinicalTrials.gov