Status:
COMPLETED
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
Lead Sponsor:
AstraZeneca
Conditions:
Diabetes Mellitus
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief 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) r...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01192152
Start Date
November 1 2009
End Date
December 1 2009
Last Update
May 12 2015
Active Locations (1)
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1
PPD Development, LP
Austin, Texas, United States, 78744