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
Condition: Diabetes Mellitus
Intervention: saxagliptin; Glucophage XR; saxagliptin + metformin XR (FDC tablet)
Intervention description: Tablets, Oral, 5 mg, once daily, Single dose; Tablets, Oral, 500 mg, once daily, Single dose; Tablet, Oral, (saxagliptin 5 mg)(metformin XR 1000 mg), once daily, 4 days
Intervention MeSH terms: Metformin; Saxagliptin
Phase: Phase 1
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to demonstrate bioequivalence (BE) of a 5 mg saxagliptin/1000 mg
      metformin extended release (XR) fixed-dose combination (FDC) tablet (manufactured in Mt
      Vernon, Indiana) relative to a coadministered 5 mg Onglyza tablet (saxagliptin, manufactured
      in Mt Vernon, Indiana) and two 500 mg Glucophage XR tablets (metformin XR, manufactured in
      Evansville, Indiana) in the fed state in healthy subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male and female subjects as determined by no clinically significant deviation
             from normal in medical history, physical examination, ECGs, and clinical laboratory
             determinations

          -  Body Mass Index (BMI) of 18 to 32 kg/m², inclusive

          -  Ages 18 to 55, inclusive

        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