A study to assess the bioequivalence of fixed dose combination of dapagliflozin/metformin XR relative to co-administration of the individual components in healthy Chinese subjects.

Exclusion Criteria

• 1. Any significant acute or chronic medical illness.
• 2. Current or recent (within 3 months prior to study drug administration) gastrointestinal
• disease that may impact drug absorption and affect PK of the study drugs. Additionally,
• any gastrointestinal surgery (eg, partial gastrectomy, pyloroplasty) that could impact the absorption of study drug.
• 3. Any major surgery, as determined by the investigator, within 4 weeks prior to study drug administration.
• 4. Donation of blood within 3 months prior to study drug administration.
• 5. Blood transfusion within 4 weeks prior to study drug administration.
• 6. Inability to tolerate oral medication.
• 7. Inability to tolerate venous access.
• 8. Drug or alcohol abuse within 6 months prior to study drug administration. Alcohol abuse
• is defined as a history of regular alcohol consumption exceeding 14 drinks per week, or a positive breath alcohol test at screening and/or check-in. 1 drink equals to 5 ounces (150ml) of wine or 12 ounces (360 ml) of beer or 1.5 ounces (45 ml) of hard liquor.
• 9. Regularly drink more than 3 cups of coffee or other caffeine-containing products a day, or
• 5 cups of tea a day.
• 10. Regular smoker (the subject should be able to abstain from smoking for the duration of the
• study without having abstinence, therefore they should not be regular smokers, regular
• smokers are defined as people who smoke everyday), use of tobacco-containing or
• nicotine-containing products (including but not limited to cigarettes, pipes, cigars,
• chewing tobacco, nicotine patches, nicotine lozenges, or nicotine gum) within 4 weeks
• prior to study drug administration .
• 11. Any other sound medical, psychiatric and/or social reason as determined by the
• investigator.
• 12. Any of the following on ECG prior to study drug administration:
• (a) PR≥210ms
• (b) QRS≥120ms
• (c) QT≥500ms
• (d) QTcF≥450ms(male) or QTcF≥470ms(female)
• 13. Positive urine screen for drugs of abuse.
• 14. Any clinically significant abnormal findings in urinalysis (may repeat once) at screening,
• as judged by the investigator.
• 15. Glucosuria at screening.
• 16. Abnormal liver function tests (alanine aminotransferase [ALT], aspartate aminotransferase
• [AST], or total bilirubin > 10% above upper limit of normal [ULN]).
• 17. Elevated serum creatinine (> ULN).
• 18. Positive blood screen for HIV antibody , Syphilis antibody, hepatitis C antibody , or
• Hepatitis B surface antigen (HbsAg) or only Hepatitis B core antibody (anti-HBc) in
• Hepatitis B serologic test.
• 19. History of allergy to SGLT2 inhibitor drug class or related compounds.
• 20. History of allergy or intolerance to metformin or other similar acting agents.
• 21. History of any significant drug allergy (such as anaphylaxis or hepatotoxicity).
• 22. Prior exposure to metformin or dapagliflozin within 3 months of study drug
• administration.
• 23. Exposure to any investigational product or placebo within 4 weeks prior to study drug
• administration.
• 24. Use of any prescription drugs or over-the counter (OTC), traditional Chinese medicine and
• herbal preparations within 4 weeks prior to study drug administration.
• 25. Involvement in the planning and/or conduct of the study (applies to AstraZeneca staff or
• staff at the study site).
• 26. Previous enrolled or randomized in the present study.
• 27. For women only - currently pregnant (confirmed with positive pregnancy test) or breastfeeding.
• 28. Judgment by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements.
• 29. Has clinical signs and symptoms consistent with COVID-19 infection (eg fever, dry cough, dyspnea, sore throat, fatigue.. etc) as judged by investigator or confirmed infection by appropriate laboratory test within the last 4 weeks prior to screening or on admission.
• 30. History of COVID-19.