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

Launched by ASTRAZENECA · Aug 30, 2010

Keywords

ClinConnect Summary

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)

Gender

ALL

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