Bioequivalence Study of the Fixed Dose Combination of 5 mg Saxagliptin/1000 mg Metformin XR (Manufactured in Mt Vernon, IN) Relative to 5 mg of Onglyza and 2 × 500 mg Glucophage XR

Exclusion Criteria

• - Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations beyond what is consistent with the target population
• - Major surgical procedure within 4 weeks prior to randomization
• - Positive serology test for HIV, HBV or HCV
• - Clinically significant history or presence of any of the following conditions: heart, liver, or kidney disease, neurologic or psychiatric disease
• - History of gastrointestinal disease within the past 3 months
• - Any clinically significant medical condition that could potentially affect your participation in the study and/or personal well-being, as judged by the investigator
• - Donated blood or blood products to a blood bank, blood transfusion or participated in a clinical study (except a screening visit) requiring withdrawal of blood within 4 weeks prior to randomization
• - Unable to tolerate oral and/or intravenous (IV) medications
• - Unable to tolerate the puncturing of veins for drawing of blood
• - Known allergy or hypersensitivity to any component of the study medication
• - History of any significant drug allergies (such as anaphylaxis or hepatotoxicity)
• - Used any prescription drugs or over the counter products to control acid (for example, Prevacid, Mylanta or Rolaids) within 4 weeks prior to randomization
• - Used any other drugs including over the counter medications and herbal preparations within 1 week prior to randomization
• - Taken any investigational drug or placebo (inactive drug) within 4 weeks prior to randomization