Pharmacokinetics of a Fixed Dose Combination of Canagliflozin/Metformin Coadministered With Food

This is a randomized (a sequence of fasted and fed periods accompanying study drug intake
will be assigned by chance), open-label (physicians and participants know the identity of
the assigned treatment), single-center, single-dose, 2-period, 2-sequence, crossover study
of Canagliflozin/extended release Metformin (CANA/MET XR) fixed dose combination (FDC)
tablet of 150 mg/1,000 mg. Approximately 24 healthy adult participants will be enrolled to
ensure that at least 20 complete the study.

After a screening period, participants will be randomly assigned to 1 of the 2 treatment
sequences (AB or BA) on Day 1 of Period 1. Treatment A means a participant will receive a
single 150/1,000 mg CANA/MET XR FDC tablet under fasted conditions, and Treatment B means
that a participant will receive the same drug under fed conditions. Participants will need
to remain at the study center for 4 days (72 hours postdose) after the drug administration
for collection of blood samples in each treatment period. There will be a 10- to 14-day
washout period between Period 1 and Period 2. On Day 4 (72 hours postdose) of Period 2, when
participants are discharged from the study center, they will be given instructions to return
for a follow-up visit 7 to 10 days later. For Treatment B (in fed state), participants will
be provided with a standardized high-fat breakfast. Participants' safety will be monitored
throughout the study.

Inclusion Criteria:

- Must sign an informed consent document indicating they understand the purpose of the
study and procedures

- Must have a body mass index (BMI) of between 18 and 30 kg/m², inclusive

- Must have a body weight of not less than 50 kg

- Must have a blood pressure between 90 and 140 mmHg inclusive, systolic, and no higher
than 90 mmHg diastolic at screening

- Must have normal renal function and no evidence of kidney damage (including
abnormalities in blood or urine tests)

Exclusion Criteria:

- History of or current clinically significant medical illness

- Use of any prescription or nonprescription medication (including vitamins and herbal
supplements)

- History of clinically significant allergies, especially known hypersensitivity or
intolerance to lactose- Known allergy to heparin or history of heparin induced
thrombocytopenia

- History of smoking or use of nicotine-containing substances within the previous 2
months