Bioequivalence Study of Saxagliptin and Glucophage Combination Formulations in Healthy Subjects (B)
Study identifier:CV181-092
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 1000 mg Metformin Immediate Release (IR) Tablet Relative to 2.5 mg Saxagliptin Tablet and 1000 mg Metformin IR Tablet Co-administered to Healthy Subjects in a Fasted and in a Fed State
Medical condition
Type 2 Diabetes Mellitus
Phase
Phase 1
Healthy volunteers
Yes
Study drug
Saxagliptin, Metformin IR (glucophage), Saxagliptin + Metformin IR (FDC)
Sex
All
Actual Enrollment
24
Study type
Interventional
Age
19 Years - 45 Years
Date
Study Start Date: 01 Jun 2009
Primary Completion Date: 01 Jul 2009
Study Completion Date: 01 Jul 2009
Study design
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Other
Verification:
Verified 01 May 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: Arm A Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fasted conditions | Drug: Saxagliptin Tablet, Oral, 2.5 mg, Once Daily, 1 week Other Name: Onglyza Drug: Metformin IR (glucophage) Tablets, Oral, 1000 mg, Once Daily, 1 week Other Name: Glucophage |
| Other: Arm B Single oral dose of a FDC tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fasted conditions | Drug: Saxagliptin + Metformin IR (FDC) Tablet, Oral, Saxagliptin 2.5 mg + metformin IR 1000 mg, Once Daily, 1 Week Other Name: Onglyza Other Name: Glucophage |
| Other: Arm C Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fed conditions with a standard meal | Drug: Saxagliptin Tablet, Oral, 2.5 mg, Once Daily, 1 week Other Name: Onglyza Drug: Metformin IR (glucophage) Tablets, Oral, 1000 mg, Once Daily, 1 week Other Name: Glucophage |
| Other: Arm D Single oral dose of a FDC tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fed conditions with a standard meal | Drug: Saxagliptin + Metformin IR (FDC) Tablet, Oral, Saxagliptin 2.5 mg + metformin IR 1000 mg, Once Daily, 1 Week Other Name: Onglyza Other Name: Glucophage |
Contacts
Investigators
Principal Investigator
Bristol-Myers Squibb
Bristol-Myers Squibb
