Overview

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

Status:
Completed
Trial end date:
2010-03-01
Target enrollment:
0
Participant gender:
All
Summary
To demonstrate bioequivalence of a 2.5 mg saxagliptin/850 mg metformin fixed dose combination (FDC) tablet relative to the 2.5 mg saxagliptin tablet and 850 mg metformin (Glucophage Marketed by Merck-Serono) tablet co-administered to healthy subjects in the fasted and fed condition.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
AstraZeneca
Treatments:
Metformin
Saxagliptin
Criteria
Inclusion Criteria:

- Men and women ages 18 to 55 inclusive

- Healthy subjects as determined by no clinically significant deviation from normal in
medical history, physical examination, electrocardiograms (ECGs), and clinical
laboratory determinations

- Body Mass Index (BMI) of 18 to 32 kg/m^2, inclusive. BMI = weight (kg)/ [height (m)]^2

Exclusion Criteria:

- Any significant acute or chronic medical illness

- Current or recent (within 3 months) gastrointestinal disease

- Any major surgery within 4 weeks of study drug administration

- History of allergy to a dipeptidyl peptidase-IV (DPP4) inhibitor or related compound

- History of allergy or intolerance to metformin or other similar acting agents

- Prior exposure to saxagliptin

- Prior exposure to metformin within 3 months of study drug administration

- Estimated creatinine clearance (Clcr) of < 80 mL/min using the Cockcroft Gault formula