Bioequivalence Study
Study identifier:CV181-208
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
Bioequivalence Study of the Fixed Dosed Combination of 5 mg Saxagliptin and 1000 mg Metformin Extended Release Tablet Manufactured in Mt. Vernon, Indiana and Humacao, Puerto Rico Relative to the Fixed Dosed Combination Tablet Manufactured in Mt. Vernon, Indiana and Bioequivalence Study of the Fixed Dosed Combination of 5 mg Saxagliptin and 500 mg Metformin Extended Release Tablet Manufactured in Mt. Vernon, Indiana and Humacao, Puerto Rico Relative to the Fixed Dosed Combination Tablet Manufactured in Mt. Vernon, Indiana Administered to Healthy Subjects under Fed Conditions
Medical condition
diabetes
Phase
Phase 1
Healthy volunteers
Yes
Study drug
Saxagliptin/Metformin
Sex
All
Actual Enrollment
56
Study type
Interventional
Age
18 Years - 45 Years
Date
Study Start Date: 01 Jun 2013
Primary Completion Date: 01 Jul 2013
Study Completion Date: 01 Jul 2013
Study design
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Other
Verification:
Verified 01 Mar 2015 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
AstraZeneca
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Arm A: Saxagliptin/Metformin XR FDC (Mt. Vernon/Humacao) Saxagliptin 5 mg /Metformin 1000 mg (Mt. Vernon/Humacao) tablet by mouth once daily on Day 1 of Periods 1 and 2 | - |
| Experimental: Arm B: Saxagliptin/Metformin XR FDC (Mt. Vernon) Saxagliptin 5 mg/Metformin 1000 mg (Mt. Vernon) tablet by mouth once daily on Day 1 of Periods 1 and 2 | - |
| Experimental: Arm C: Saxagliptin/Metformin XR FDC (Mt. Vernon/Humacao) Saxagliptin 5 mg/Metformin 500 mg (Mt. Vernon/Humacao) tablet by mouth once daily on Day1 of Periods 1 and 2 | - |
| Experimental: Arm D: Saxagliptin/Metformin XR FDC (Mt. Vernon) Saxagliptin 5 mg/Metformin 500 mg (Mt. Vernon) tablet by mouth once daily Day 1 of Periods 1 and 2 | - |
Contacts
Investigators
Principal Investigator
Bristol-Myers Squibb
Bristol-Myers Squibb
