A Bioequivalence Study of the Fixed Dose Combinations of Saxagliptin/Metformin XR Relative to Co-Administration - SAXA
Study identifier:D1681C00001
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Single-centre, Randomized, Open-label, Two-period, Cross-over, Bioequivalence Study of the Fixed Dose Combinations of Saxagliptin/Metformin XR Relative to Co-Administration of the Individual Components in two cohorts of Healthy Chinese Subjects under Fed Conditions
Medical condition
type 2 diabetes mellitus(T2DM)
Phase
Phase 1
Healthy volunteers
Yes
Study drug
Saxagliptin 5 mg, Metformin XR 500 mg, Mertformin XR 2 x 500 mg, Komboglyze XR 5/500 mg, Komboglyze XR 5/1000 mg
Sex
Male
Actual Enrollment
64
Study type
Interventional
Age
18 Years - 40 Years
Date
Study Start Date: 01 Feb 2013
Primary Completion Date: 01 Apr 2013
Study Completion Date: 01 Apr 2013
Study design
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Verification:
Verified 01 Jan 2014 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
Bristol Myers Squibb
Inclusion and exclusion criteria
Loading...
No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Lower dose co-administration of a single oral dose of a 5 mg saxagliptin tablet and a 500 mg metformin XR (Glucophage XR®) tablet vs. single FDC tablet consisting of 5 mg saxagliptin and 500 mg metformin XR (Kombiglyze XR) | Drug: Saxagliptin 5 mg Saxagliptin oral tablet 5mg, single dose Drug: Metformin XR 500 mg Metformin XR oral tablet 500 mg, single dose Drug: Komboglyze XR 5/500 mg oral FDC tablet (saxagliptin 5 mg and metformin 500 mg), single dose |
| Experimental: Higher dose co-administration of a single oral dose of a 5 mg saxagliptin tablet and two (2) 500 mg metformin XR (Glucophage XR®) tablets vs. Single FDC tablet consisting of 5 mg saxagliptin and 1000 mg metformin XR (Kombiglyze XR) | Drug: Saxagliptin 5 mg Saxagliptin oral tablet 5mg, single dose Drug: Mertformin XR 2 x 500 mg Metformin XR oral tablet 2 x 500 mg, single dose Drug: Komboglyze XR 5/1000 mg oral FDC tablet (saxagliptin 5 mg and metformin 1000 mg), single dose |
Contacts
Investigators
Principal Investigator
Boaz Hirshberg
Room No.: C3C-718, 1800 Concord Pike, PO Box 15437, Wilmington DE 19850-5437, USA
