Drug Interaction Study of Saxagliptin in Combination With Dapagliflozin in Healthy Participants

A Single-dose, Open-label, Randomized, 3 Period, 3 Treatment Crossover Study to Evaluate the Pharmacokinetics of Saxagliptin 5 mg and Dapagliflozin 10 mg When Coadministered to Fasted Healthy Subjects

The purpose of this study is to evaluate whether the pharmacokinetics (body concentrations/metabolism of the drug) of Saxagliptin and Dapagliflozin are affected when they are administered together

Inclusion Criteria:

• Healthy subjects as determined by no clinically significant deviation from normal in medical history, Physical Examination, vital signs, 12-lead ECG, and clinical laboratory determinations
• Body mass index (BMI) of 18 to 30 kg/m2
• Men and women, ages 18 to 45 years
• Women of childbearing potential must use acceptable methods of highly effective birth control

Exclusion Criteria:

• History of chronic or recurrent urinary tract infection for females
• History of allergies or adverse reactions to Dipeptidyl peptidase-IV (DPP4) or Sodium-glucose transporter type 2 (SGLT2) inhibitors
• Any significant acute or chronic medical illness
• Current or recent gastrointestinal disease
• Any major surgery within 4 weeks of study drug administration
• Prior exposure to saxagliptin or dapagliflozin or related drugs