Study in healthy subjects to measure amount of drug in blood after dosing with different saxagliptin / metformin produc

Study identifier:D1681C00004

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

Bioequivalence Study of the Fixed-dose Combination of Saxagliptin/Metformin XR Tablets Relative to Saxagliptin (Onglyza� ) Tablets and Australia-sourced Diabex XR Tablets Coadministered to Healthy Subjects in the Fed State During Steady-state Administration

Medical condition

bioequivalence, log-transformed AUCss and Cmax,ss values for saxagliptin and metformin

Phase

Phase 1

Healthy volunteers

Yes

Study drug

Onglyza (saxagliptin), Diabex, 5-mg saxagliptin/1000 mg metformin, 5-mg saxagliptin/500 mg metformin

Sex

All

Actual Enrollment

28

Study type

Interventional

Age

18 Years - 55 Years

Date

Study Start Date: 01 Oct 2011
Primary Completion Date: 01 Dec 2011
Study Completion Date: 01 Dec 2011

Study design

Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science

Verification:

Verified 01 Nov 2013 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria