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

• Status: Withdrawn
• Trial end date: 2011-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to demonstrate the bioequivalence (BE) of Saxagliptin and Metformin from a 5 mg Saxagliptin/500 mg Metformin extended release (XR) fixed dose combination (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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: AstraZeneca
• Treatments: Metformin; Saxagliptin

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