A Bioequivalence Study of the Fixed Dose Combinations of Saxagliptin/Metformin XR Relative to Co-Administration

• Status: Completed
• Trial end date: 2013-04-01
• Target enrollment: 0
• Participant gender: Male

Summary

The primary objective of this study is to assess the pharmacokinetic parameters of saxagliptin and metformin in healthy male Chinese subjects.

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

Details

• Lead Sponsor: AstraZeneca
• Collaborator: Bristol-Myers Squibb
• Treatments: Metformin; Saxagliptin

Criteria

Inclusion Criteria:

• Chinese ethnicity which is defined as having both parents and 4 grandparents who are Chinese

• Healthy male subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations

• Men, ages 18 to 40 years, inclusive. The age difference among the subjects is within 10 years

• Weigh at least 50 kg and have a body mass index (BMI) between 19 and 24 kg/m2

• Sexually active fertile men must use effective birth control throughout the study and for up to 90 days after the last dose of investigational product if their partners are women of child bearing potential

Exclusion Criteria:

• Any significant acute or chronic medical illness

• Current or recent gastrointestinal disease

• Subjects that have lymphocytopenia or thrombocytopenia

• History of autoimmune skin disorder

• Estimatedcreatinine clearance of less than 80 mL/min