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

• Status: Completed
• Trial end date: 2012-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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

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

Details

• Lead Sponsor: AstraZeneca
• Treatments: Dapagliflozin; Saxagliptin

Criteria

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