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
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
AstraZeneca
This study is designed to evaluate if the FDC tablet of 5 mg saxagliptin/1000 mg metformin extended release (manufactured in Mt Vernon, Indiana) is bioequivalent to the coadministered 5 mg saxagliptin tablet plus 2 x 500 mg Glucophage XR tablets (manufactured in Evansville, Indiana)
Age
18–45
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
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
You may not be if
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
Clareo Health | 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
