A Study to Evaluate the Food Effect on Drug Availability, Pharmacokinetic (PK) Properties, Safety and Tolerability of Two Different Dose Combination Therapy of Saxagliptin/Dapagliflozin/Metformin Extended-release (XR) Against Individual Component Co-administration.

This study will be randomized, 3-period, 3-treatment, single-dose, open-label, single-center,
crossover to assess the fed-state bioequivalence of a two triple Fixed-combination Drug
Product (FCDP) of saxagliptin/dapagliflozin/metformin extended-release (XR) relative to
individual components co-administered in approximately 84 healthy adult subjects. Eligible
subjects will be healthy male and female aged 18 to 55 years, with a body weight of 50 to 100
kg and body mass index (BMI) of 18 to 32 kg/m2. Of the 84 randomized subjects (2 cohorts of
42 subjects each [3 treatments in each cohort]), at least 72 subjects (36 in each cohort)
should be evaluable. Each randomized subject will receive 3 single-dose treatments and each
treatment will be administered within 1 of the 3 successive treatment periods. Within each
cohort subjects will be randomized to 1 to 6 treatment sequences prescribing the ordered
sequence of 3 administered treatments with 7 subjects in each treatment sequence. The
investigational medicinal product (IMPs) will be administered orally at single-dose to
subjects within 5 minutes after standard meal (light-fat, low-calorie) in the morning (fed
condition) or following a 10 hour fast (fasted condition). In both cohorts, test product will
be compared with treatments of fed and fasted conditions Subjects in Cohort 1 will be
randomized to one of the treatment sequences (ABC), (ACB), (BAC), (BCA), (CAB) or (CBA).

Treatment A (Reference Product under fed conditions) - Single-dose of 2.5 mg saxagliptin
(ONGLYZA) and 5 mg dapagliflozin / 1000 mg metformin XR (XIGDUO XR) tablets.

Treatment B (Test Product under fed conditions) - Single-dose of triple FCDP consisting of
2.5 mg saxagliptin / 5 mg dapagliflozin / 1000 mg metformin XR.

Treatment C (Test Product fasted conditions) - Single-dose of triple FCDP tablet consisting
of 2.5 mg saxagliptin / 5 mg dapagliflozin / 1000 mg metformin XR.

Subjects in Cohort 2 will be randomized to one of the treatment sequences (DEF), (DFE),
(EDF), (EFD), (FDE) or (FED).

Treatment D (Reference product under fed conditions) - Single-dose of 5 mg saxagliptin
(ONGLYZA) and 10 mg dapagliflozin / 1000 mg metformin XR (XIGDUO XR) tablet.

Treatment E (Test Product under fed conditions) - Single-dose of triple FCDP consisting of 5
mg saxagliptin / 10 mg dapagliflozin / 1000 mg metformin XR.

Treatment F (Test Product under fasted conditions) - Single-dose of triple FCDP consisting of
5 mg saxagliptin / 10 mg dapagliflozin / 1000 mg metformin XR.

The study will comprise:

- A screening period of maximum 28 days;

- Three resident treatment periods - Day before dosing with the IMP (Day -1) until at
least 72 hours after dosing; and will be discharged on the morning of Day 4; and

- A follow-up visit within 5 to 7 days after the last dose of IMP. Treatment periods will
be separated by a minimum washout period of 7 to 14 days between each IMP dose. The
duration of the study will be approximately 7 to 9 weeks.

Inclusion Criteria:

1. Provision of signed and dated, written informed consent prior to any study specific
procedures.

2. Healthy male and/or female subjects aged 18 to 55 years with suitable veins for
cannulation or repeated venipuncture.

3. Female subject must have a negative serum pregnancy test (minimum sensitivity 25 IU/L
or equivalent units of human chorionic gonadotropin) at Screening and negative urine
pregnancy test within 24 hours prior to investigational medicinal product (IMP)
administration and either: a) Be of non-childbearing potential, confirmed at screening
by fulfilling one of the following criteria: - Postmenopausal defined as amenorrhea
for at least 12 months or more following cessation of all exogenous hormonal
treatments and FSH levels in the postmenopausal range.

- Documentation of irreversible surgical sterilization by hysterectomy, bilateral
oophorectomy or bilateral salpingectomy but not tubal ligation.

b). Or, if of childbearing potential: - Must not be nursing (breastfeeding). -And, if
heterosexually active, agree to consistently use an acceptable method of contraception
to avoid pregnancy, from at least 4 weeks prior to dosing and throughout the study and
for up to 90 days after the last dose of IMP.

4. Sexually active fertile male subjects must use effective birth control for the entire
study and 90 days after the last dose of IMP if their partners are women of
childbearing potential.

5. Have a body mass index (BMI) between 18 and 32 kg/m2 inclusive and weigh at least 50
kg and no more than 100 kg inclusive.

Exclusion Criteria:

1. History of any clinically significant disease or disorder which, in the opinion of the
principal investigator (PI), may either put the volunteer at risk because of
participation in the study, or influence the results or the volunteer's ability to
participate in the study.

2. Current or recent (within 3 months of first IMP dosing) gastrointestinal (GI) disease
that may impact drug absorption and affect the PK of the study drugs. Additionally,
any GI surgery (e.g., partial gastrectomy, pyloroplasty) including cholecystectomy
that may impact drug absorption.

3. Any major surgery, as determined by the investigator, within 4 weeks of first IMP
dosing.

4. Donation of > 400 mL of blood within 8 weeks or donation of plasma (except at the
Screening Visit) within 4 weeks of first IMP dosing.

5. Blood transfusion within 4 weeks of first IMP dosing.

6. Inability to tolerate oral medication.

7. Inability to tolerate venipuncture or inadequate venous access as determined by the
investigator.

8. Recent (within 6 months of first IMP dosing) drug or alcohol abuse as defined in the
Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV),
Diagnostic Criteria for Drug and Alcohol Abuse.

9. Subjects who drink more than 3 cups of coffee or other caffeine-containing products a
day, or 5 cups of tea a day.

10. 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 6 months prior to first check-in (Day -1, Treatment Period 1), or
a positive nicotine test (i.e., cotinine) at Screening and/or check-in.

11. History of diabetes mellitus, heart failure, chronic or recurrent urinary tract
infection (defined as 3 occurrences per year) and severe allergy/hypersensitivity or
ongoing allergy/hypersensitivity, as judged by the PI or history of hypersensitivity
to drugs with a similar chemical structure or class to saxagliptin, dapagliflozin and
metformin.

14. Recent vulvovaginal mycotic infection (within 2 months prior to first IMP dosing).

15. Any other sound medical, psychiatric and/or social reason as determined by the
investigator.

16. Any clinically significant illness, medical/surgical procedure, or trauma within 4
weeks of Screening.

17. Any positive result on screening for serum hepatitis B surface antigen, hepatitis C
antibody, and human immunodeficiency virus (HIV) antibody.

18. Has received another new chemical entity (defined as a compound which has not been
approved for marketing) within 3 months of the first administration of IMP in this study.
The period of exclusion begins 3 months after the final dose or one month after the last
visit whichever is the longest.

19. Positive screen for drugs of abuse or cotinine at Screening or on each admission to the
clinical unit or positive screen for alcohol on each admission to the clinical unit.

20. Use of saxagliptin, dapagliflozin and/or metformin within 3 months prior to the first
administration of IMP.

21. Use of any prescription drugs or over the counter acid controllers within 4 weeks prior
to the first administration of IMP except medication cleared by the medical monitor.

22. Use of drugs with enzyme-inducing properties such as St John's Wort within 3 weeks
prior to the first administration of IMP.

23. Use of any prescribed or non-prescribed medication including analgesics (other than
paracetamol / acetaminophen), herbal remedies, megadose vitamins (intake of 20 to 600 times
the recommended daily dose) and minerals during the 2 weeks prior to the first
administration of IMP or longer if the medication has a long half-life. Note: Hormonal
replacement therapy is not allowed.

24. Involvement of any AstraZeneca, PAREXEL or study site employee or their close
relatives.

25. Vulnerable subjects, e.g., kept in detention, protected adults under guardianship,
trusteeship, or committed to an institution by governmental or juridical order.