Bioequivalence Study of 2.5-mg Saxagliptin and 500-mg Glucophage in Tablets and a Fixed-dose Combination Tablet in Healthy Participants
Study identifier:CV181-118
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 500 mg Metformin Tablet Relative to a 2.5 mg Saxagliptin (Onglyza) Tablet and a 500 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
Saxagliptin, 2.5 mg + Metformin, 500 mg (fasted state), Saxagliptin, 2.5 mg /Metformin, 500 mg FDC (fasted state), Saxagliptin, 2.5 mg + Metformin, 500 mg (fed state), Saxagliptin, 2.5 mg /Metformin, 500 mg FDC (fed state)
Sex
All
Actual Enrollment
27
Study type
Interventional
Age
18 Years - 55 Years
Date
Study Start Date: 01 Mar 2010
Primary Completion Date: 01 Mar 2010
Study Completion Date: 01 Mar 2010
Study design
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Other
Verification:
Verified 01 Apr 2015 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
Astra-Zeneca
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Other: Saxagliptin, 2.5 mg + Metformin, 500 mg (fasted state) Single oral doses of saxagliptin, 2.5 mg, and metformin, 500 mg, administered together as tablets in the fasted state | Drug: Saxagliptin, 2.5 mg + Metformin, 500 mg (fasted state) Tablets, oral, 2.5-mg saxagliptin and 500-mg metformin, once daily, 1 week Other Name: Onglyza™ Other Name: Glucophage™ |
| Other: Saxagliptin, 2.5 mg/Metformin, 500 mg FDC (fasted state) Single oral dose of a 2.5-mg saxagliptin/500-mg metformin fixed-dose combination (FDC) tablet administered in the fasted state | Drug: Saxagliptin, 2.5 mg /Metformin, 500 mg FDC (fasted state) Tablets, oral, 2.5-mg saxagliptin/500-mg metformin fixed-dose combination (FDC), once daily, 1 week |
| Other: Saxagliptin, 2.5 mg + Metformin, 500 mg (fed state) Single oral doses of saxagliptin, 2.5 mg, and metformin, 500 mg, administered together as tablets in the fed state | Drug: Saxagliptin, 2.5 mg + Metformin, 500 mg (fed state) Tablets, oral, 2.5-mg saxagliptin and 500-mg metformin, once daily, 1 week Other Name: Onglyza™ Other Name: Glucophage™ |
| Other: Saxagliptin, 2.5 mg/Metformin, 500 mg FDC (fed state) Single oral dose of saxagliptin, 2.5 mg/metformin, 500 mg, FDC tablet administered in the fed state | Drug: Saxagliptin, 2.5 mg /Metformin, 500 mg FDC (fed state) Tablets, oral, 2.5-mg saxagliptin and 500-mg metformin FDC, once daily, 1 week |
Contacts
Investigators
Principal Investigator
Bristol-Myers Squibb
Bristol-Myers Squibb
