Bioequivalence/Food Effect - Saxa/Dapa Dual Fixed Dose Combination (FDC)

• Status: Completed
• Trial end date: 2014-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to demonstrate the bioequivalence (BE) of Saxagliptin and Dapagliflozin from a 2.5-mg Saxagliptin/5-mg Dapagliflozin FDC tablet after oral administration relative to 2.5-mg Saxagliptin and 5-mg Dapagliflozin tablets administered orally together in the fasted state and to demonstrate the BE of Saxagliptin and Dapagliflozin from a 5-mg Saxagliptin/10-mg Dapagliflozin FDC tablet after oral administration relative to 5-mg Saxagliptin and 10-mg Dapagliflozin tablets administered orally together in the fasted state. Demonstrating bioequivalence refers to showing that the FDC tablet and co-administration of the individual components yield similar blood levels/concentrations of the drug and are handled by the body similarly.

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

Details

• Lead Sponsor: AstraZeneca
• Treatments: Dapagliflozin; Saxagliptin

Criteria

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Inclusion Criteria:

• Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination (PE), vital signs, 12-lead ECG, and clinical laboratory determinations

• Body mass index (BMI) of 18.5 to 30 kg/m(2)

• Men and women, ages 18 to 50 years

• Women of childbearing potential must use acceptable methods of highly effective birth control

Exclusion Criteria:

• Any significant acute or chronic medical illness

• Current or recent gastrointestinal disease

• Any major surgery within 4 weeks of study drug administration

• History of chronic or recurrent urinary tract infection for females

• History of glucose intolerance or diabetes mellitus

• History of allergies or adverse reactions to Dipeptidyl peptidase-IV (DPP4) or Sodium-glucose cotransporter (SGLT) inhibitors

• Prior exposure to Saxagliptin or Dapagliflozin or related drugs