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)
Completed · Phase 1
Conditions studied: Diabetes Mellitus
In brief
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.
Key facts
- Study ID
- NCT01192139
- Run by
- AstraZeneca
- People needed
- 30
- Starts
- 2009-11-01
- Expected to finish
- 2009-12-01
- Last updated by the study team
- 2015-05-21
Who can join
Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify 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 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
Where it is running
- Ppd Development, Lp — Austin, Texas, United States
Full record on ClinicalTrials.gov
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