Bioequivalence Study of Fixed-dose Combinations and Coadministered Individual Tablets of Saxagliptin/Metformin-Brazil

Bioequivalence Study of Fixed Dose Combinations of Saxagliptin/Metformin Extended Release (XR) Relative to Co-administration of the Individual Components in Healthy Subjects in the Fasted and Fed States

To demonstrate the bioequivalence of saxagliptin and metformin in a saxagliptin, 5-mg/metformin extended-release (XR), 500-mg, fixed-dose combination (FDC) tablet with saxagliptin, 5-mg and metformin, 500-mg XR tablets administered together in both the fasted and fed states. In addition, to demonstrate the bioequivalence of saxagliptin and metformin in a saxagliptin, 5-mg/metformin XR, 1000-mg, FDC tablet with saxagliptin, 5-mg and metformin, 1000-mg XR tablets administered together in both the fasted and fed states.

Key Inclusion Criteria:

• Healthy men and women
• women of childbearing potential who are using acceptable method of contraception
• Women who are not pregnant or nursing
• Body Mass Index (BMI) of 18 to 29.9 kg/m^2, inclusive. BMI=weight(kg)/height(m)^2.

Key Exclusion Criteria:

• Any significant acute or chronic medical illness.
• History of gastrointestinal (GI) disease
• Major surgery within 4 weeks of study drug administration
• Any GI surgery that could impact study drug absorption
• Donation of blood or plasma to a blood bank or in a clinical study (except a screening visit) within the 6 months of study drug administration.
• Blood transfusion within 3 months of study drug administration for women and within 2 months for men
• Inability to be venipunctured and/or tolerate venous access
• Current smoker or recent (within 1 month) history of regular tobacco use
• Recent (within 6 months of study drug administration) drug or alcohol abuse
• Participation in a bioequivalence study within the last 6 months of study drug administration
• Estimated creatinine clearance of <80 mL/min using Cockcroft-Gault formula
• History of allergy to drug class or related compounds
• History of allergy to metformin or other similar acting agents
• History of any significant drug allergy