Bioequivalence Study of the Fixed Dose Combination of 5 mg Saxagliptin and 500 mg Metformin XR Tablet (Manufactured in Mt Vernon, IN) Relative to 5 mg Saxagliptin Tablet and 500 mg Metformin XR Tablet (Manufactured in Evansville, IN)

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to demonstrate bioequivalence (BE) of a 5 mg saxagliptin/500 mg metformin extended release (XR) fixed-dose combination (FDC) tablet (manufactured in Mt Vernon, Indiana [IN]) to coadministered 5 mg saxagliptin and 500 mg metformin XR tablet (manufactured in Evansville, IN) in fed healthy subjects.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: AstraZeneca
• Treatments: Metformin; Saxagliptin

Criteria

Inclusion Criteria:

• Healthy male and female subjects as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiogram (ECG), and clinical laboratory determinations

• Body Mass Index (BMI) of 18 to 32 kg/m2, inclusive

• Ages 18 to 45, 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 human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (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