A Bioequivalence Study of the Fixed Dose Combinations of Saxagliptin/Metformin XR Relative to Co-Administration - SAXA

Study identifier:D1681C00001

ClinicalTrials.gov identifier:NCT01755494

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

Study type

Interventional

Age

18 Years - 40 Years

Date

Study Start Date: 25 Feb 2013

Primary Completion Date: 26 Apr 2013

Study Completion Date: 26 Apr 2013

Study design

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

Verification:

Verified 01 Jun 2025 by AstraZeneca

Collaborators

Bristol Myers Squibb

Inclusion and exclusion criteria

Location

Research Site

Beijing, China

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

"There is no result for the study"

Documents available

Download
Redacted CSR Synopsis
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information

800-236-9933

ClinicalTrialTransparency@astrazeneca.com

Investigators

Principal Investigator

Boaz Hirshberg

Room No.: C3C-718, 1800 Concord Pike, PO Box 15437, Wilmington DE 19850-5437, USA