Bioequivalence Study of Saxagliptin and Glucophage Combination Formulations in Healthy Subjects (B)

Study identifier:CV181-092

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 2.5 mg Saxagliptin and 1000 mg Metformin Immediate Release (IR) Tablet Relative to 2.5 mg Saxagliptin Tablet and 1000 mg Metformin IR Tablet Co-administered to Healthy Subjects in a Fasted and in a Fed State

Medical condition

Type 2 Diabetes Mellitus

Phase

Phase 1

Healthy volunteers

Yes

Study drug

Saxagliptin, Saxagliptin, Metformin IR (glucophage), Metformin IR (glucophage), Saxagliptin + Metformin IR (FDC), Saxagliptin + Metformin IR (FDC)

Sex

All

Actual enrollment

24

Study type

Interventional

Age

19 Years - 45 Years

Date

Study Start Date: 01 Jun 2009
Primary Completion Date: 01 Jul 2009
Study Completion Date: 01 Jul 2009

Study design

Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Other

Verification:

Verified 01 May 2015 by AstraZeneca Pharmaceuticals

Sponsors

AstraZeneca Pharmaceuticals

Collaborators

Astra-Zeneca

Inclusion and exclusion criteria