Bioequivalence Study of Fixed Dose Combination of 2.5 mg Saxagliptin/850 mg Metformin Tablet relative to 2.5 mg Onglyza and 850 mg Glucophage Tablets Co-Administered
Study identifier:CV181-121
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 850 mg Metformin Tablet Relative to a 2.5 mg Saxagliptin (Onglyza) Tablet and a 850 mg Metformin (Glucophage Marketed by Merck Serono) Tablet Co-Administered to Healthy Subjects in the Fasted and Fed Conditions
Medical condition
Type 2 Diabetes Mellitus
Phase
Phase 1
Healthy volunteers
Yes
Study drug
saxagliptin, metformin, saxagliptin + metformin (FDC tablet)
Sex
All
Actual Enrollment
24
Study type
Interventional
Age
18 Years - 55 Years
Date
Study Start Date: 01 Feb 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 Mar 2015 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
Astra-Zeneca
Inclusion and exclusion criteria
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| Arms | Assigned Interventions |
|---|---|
| Other: Arm A (saxagliptin 2.5 mg + metformin 850 mg; Fasting) A single oral dose of 2.5-mg Onglyza tablet and 850-mg Glucophage (marketed by Merck Serono) tablet administered together in the fasted condition. | Drug: saxagliptin Tablets, Oral, 2.5 mg, once daily, single dose Other Name: Onglyza Drug: metformin Tablets, Oral, 850 mg, once daily, single dose Other Name: Glucophage |
| Other: Arm B (saxagliptin 2.5 mg + metformin 850 mg FDC; Fasting) A single oral dose of 2.5-mg saxagliptin/850-mg metformin fixed dose combination (FDC) administered in the fasted condition. | Drug: saxagliptin + metformin (FDC tablet) Tablet, oral, (saxagliptin 2.5 mg) (metformin 850 mg), once daily, single dose |
| Other: Arm C (saxagliptin 2.5 mg + metformin 850 mg; Fed) A single oral dose of 2.5-mg Onglyza tablet and 850-mg Glucophage (marketed by Merck Serono) tablet administered together in the fed condition. | Drug: saxagliptin Tablets, Oral, 2.5 mg, once daily, single dose Other Name: Onglyza Drug: metformin Tablets, Oral, 850 mg, once daily, single dose Other Name: Glucophage |
| Other: Arm D (saxagliptin 2.5 mg + metformin 850 mg FDC; Fed) A single oral dose of 2.5-mg saxagliptin/850-mg metformin FDC administered in the fed condition. | Drug: saxagliptin + metformin (FDC tablet) Tablet, oral, (saxagliptin 2.5 mg) (metformin 850 mg), once daily, single dose |
Contacts
Investigators
Principal Investigator
Bristol-Myers Squibb
Bristol-Myers Squibb
