Clareo Health | Bioequivalence Study of Fixed Dose Combination of 2.5 mg Saxagliptin/850 mg Metformin Tablet Relative to 2.5 mg Onglyza and 850 mg Glucophage Tablets Co-Administered
Bioequivalence Study of Fixed Dose Combination of 2.5 mg Saxagliptin/850 mg Metformin Tablet Relative to 2.5 mg Onglyza and 850 mg Glucophage Tablets Co-Administered
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
AstraZeneca
Age
18–55
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
Men and women ages 18 to 55 inclusive
Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiograms (ECGs), and clinical laboratory determinations
Body Mass Index (BMI) of 18 to 32 kg/m\^2, inclusive. BMI = weight (kg)/ \[height (m)\]\^2
You may not be if
Any significant acute or chronic medical illness
Current or recent (within 3 months) gastrointestinal disease
Any major surgery within 4 weeks of study drug administration
History of allergy to a dipeptidyl peptidase-IV (DPP4) inhibitor or related compound
History of allergy or intolerance to metformin or other similar acting agents
Prior exposure to saxagliptin
Prior exposure to metformin within 3 months of study drug administration
Estimated creatinine clearance (Clcr) of \< 80 mL/min using the Cockcroft Gault formula
