BE Study of the Fixed Dose Combination of 5 mg Saxagliptin and 500 mg Metformin HCl XR Tablet Relative to a 5 mg Saxagliptin (Onglyza™) Tablet and a 500 mg Metformin HCl XR (Glifage® XR Marketed in Brazil by Merck S.A.) Tablet Co-Administered to Healthy Subjects in the Fasted and Fed States

Launched by ASTRAZENECA · Feb 25, 2011

Keywords

ClinConnect Summary

Primary purpose: To demonstrate the bioequivalence of Saxagliptin and Metformin from a 5 mg Saxagliptin/500 mg Metformin XR FDC tablet relative to 5 mg Onglyza™ and 500 mg Glifage® XR (marketed in Brazil by Merck S.A.) tablets administered together in both the fasted and fed states.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Healthy men and women
• • Women of childbearing potential (WOCBP) who are using acceptable method of contraception
• • Women who are not nursing
• Exclusion Criteria:
• • History of Gastrointestinal (GI) disease
• • Any GI surgery that could impact study drug absorption
• • 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.
• • Estimated creatinine clearance (ClCr) \< 80 mL/min using Cockcroft-Gault formula