Bioequivalence Study

• Status: Completed
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine if tablets manufactured at different sites have the same bioavailability, that is yield similar blood levels/concentrations of the drugs and are handled by the body similarly

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

Details

• Lead Sponsor: AstraZeneca
• Treatments: Metformin; Saxagliptin

Criteria

Inclusion Criteria:

• Healthy male and female subjects, 18-45 years of age

• Body mass index (BMI) of 18.0 to 30.0 kg/m2, inclusive

• Women must have a negative serum or urine pregnancy test within 24 hours prior to the start of investigational product

Exclusion Criteria:

• Any significant acute or chronic medical illness

• Estimated creatinine clearance of <60 mL/min as calculated using the Modification of Diet in Renal Disease method Current or recent (within 3 months of study drug administration)

• Gastrointestinal (GI) disease that could affect the absorption of study drug

• Inability to tolerate oral medication

• History of allergies or adverse reactions to DPP4 inhibitors or Metformin or related compounds

• Current smoker or recent (within 6 months of study drug administration) history of regular tobacco use (positive cotinine test)