A study comparing the amount of metformin and after taking a combination tablet vs. separate tablets
Study identifier:D1691C00002
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A two part, open label, randomized, phase I bioequivalence study comparing the fixed dose combination dapagliflozin/metformin IR tablet (2.5 mg/850 mg or 5 mg/1000 mg) vs. the free combination of dapagliflozin and metformin IR tablets, in healthy volunteers, in the fed state
Medical condition
Healthy Volunteers
Phase
Phase 1
Healthy volunteers
Yes
Study drug
Dapagliflozin/Metformin, Dapagliflozin, Metformin
Sex
All
Actual Enrollment
120
Study type
Interventional
Age
18 Years - 45 Years
Date
Study Start Date: 01 Jan 2010
Primary Completion Date: 01 Apr 2010
Study Completion Date: 01 Apr 2010
Study design
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Verification:
Verified 01 Oct 2015 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
Bristol-Myers Squibb
Inclusion and exclusion criteria
Loading...
No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 Fixed dose combination dapagliflozin/metformin IR tablets followed by free combination of dapagliflozin tablet and metform IR tablet | Drug: Dapagliflozin/Metformin Fixed dose combination dapagliflozin/metformin IR tablet 2.5 mg/850 mg Oral Single dose Drug: Dapagliflozin dapagliflozin tablet 2.5 mg Oral Single dose Drug: Metformin metformin IR tablet 850 mg Oral Single dose Other Name: Glucophage |
| Experimental: 2 Free combination of dapagliflozin tablet and metform IR tablet followed by fixed dose combination dapagliflozin/metformin IR tablets | Drug: Dapagliflozin/Metformin Fixed dose combination dapagliflozin/metformin IR tablet 2.5 mg/850 mg Oral Single dose Drug: Dapagliflozin dapagliflozin tablet 2.5 mg Oral Single dose Drug: Metformin metformin IR tablet 850 mg Oral Single dose Other Name: Glucophage |
| Experimental: 3 Fixed dose combination dapagliflozin/metformin IR tablets followed by free combination of dapagliflozin tablet and metform IR tablet | Drug: Dapagliflozin/Metformin Fixed dose combination dapagliflozin/metformin IR tablet 5 mg/1000 mg Oral Single dose Drug: Dapagliflozin dapagliflozin tablet 5 mg Oral Single dose Drug: Metformin metformin IR tablet 1000 mg Oral Single dose Other Name: Glucophage |
| Experimental: 4 Free combination of dapagliflozin tablet and metform IR tablet followed by fixed dose combination dapagliflozin/metformin IR tablets | Drug: Dapagliflozin/Metformin Fixed dose combination dapagliflozin/metformin IR tablet 5 mg/1000 mg Oral Single dose Drug: Dapagliflozin dapagliflozin tablet 5 mg Oral Single dose Drug: Metformin metformin IR tablet 1000 mg Oral Single dose Other Name: Glucophage |
Contacts
Investigators
Principal Investigator
Georg Golor
PAREXEL International GmbH
