To compare the similarity of a combination Dapagliflozin/Metformin Tablet with the two drugs administered separately
Study identifier:D1691C00007
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Bioequivalence Study of the Fixed Dose Combination Dapagliflozin/Metformin Tablet (5 mg/850 mg) Relative to a 5 mg Dapagliflozin Tablet and an 850 mg Metformin (Glucophage® Marketed in Canada by Sanofi-Aventis) Tablet Co-Administered to Healthy Subjects in the Fasted and Fed States
Medical condition
Type 2 Diabetes Mellitus
Phase
Phase 1
Healthy volunteers
Yes
Study drug
Dapagliflozin + Glucophage tablet fasted, Dapagliflozin/metformin IR FDC tablet fasted, Dapagliflozin + Glucophage tablet fed, Dapagliflozin/metformin IR FDC tablet fed
Sex
All
Actual Enrollment
71
Study type
Interventional
Age
18 Years - 55 Years
Date
Study Start Date: 01 Apr 2013
Primary Completion Date: 01 Jul 2013
Study Completion Date: 01 Jul 2013
Study design
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Verification:
Verified 01 Jul 2015 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
Bristol-Myers Squibb
Inclusion and exclusion criteria
Loading...
No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 5 mg dapagliflozin and 850 mg Glucophage in fasted state | Drug: Dapagliflozin + Glucophage tablet fasted Single oral doses of 5 mg dapagliflozin and 850 mg Glucophage® tablets administered together in the fasted state |
| Experimental: 2 dapagliflozin/metformin (5 mg/850 mg) immediate release (IR) FDC in fasted | Drug: Dapagliflozin/metformin IR FDC tablet fasted single oral dose of dapagliflozin/metformin (5 mg/850 mg) IR FDC tablet in the fasted state |
| Experimental: 3 5 mg dapagliflozin and 850 mg Glucophage in fed state | Drug: Dapagliflozin + Glucophage tablet fed Single oral doses of 5 mg dapagliflozin and 850 mg Glucophage® tablets administered together in the fed state |
| Experimental: 4 dapagliflozin/metformin (5 mg/850 mg) IR FDC in fed state | Drug: Dapagliflozin/metformin IR FDC tablet fed single oral dose of dapagliflozin/metformin (5 mg/850 mg) IR FDC tablet in the fed state |
Contacts
Investigators
Principal Investigator
Eva Johnsson
AstraZeneca Research and Development SE-431 83 Mölndal Sweden
