Sotagliflozin Bioequivalence Study

The study duration per subject will be 36-99 days and will consist of a screening period of 2
to 21 days, a study period of 7 days for each of four periods, and a washout of 8-21 days
between each dose administration, and a final follow up visit 10-15 days after final dose
administration.

Inclusion criteria :

- Healthy male and female subjects 18-55 years old inclusive, male or female.

- Certified as healthy by comprehensive clinical assessment (detailed medical history
and complete physical examination).

- Body weight between 50.0 and 100.0 kg, inclusive if male, and between 40.0 and 90.0
kg, inclusive if female, Body mass index (BMI) of 18.0 to 30.0 kg/m2 inclusive.

- Normal vital signs, ECG and laboratory parameters.

- Female subjects must use a double contraception method including a highly effective
method of contraception except if she has undergone sterilization at least 3 months
earlier or is post-menopausal. Hormonal contraception is permitted in this study.

- Having given written informed consent prior to undertaking of study procedure.

- Covered by a health insurance system where applicable, and/or in compliance with the
recommendation of the national laws in force relating to biomedical research.

- Not under any administrative or legal supervision.

- Male subjects, whose partners are of childbearing potential (including lactating
women) must accept to use, during sexual intercourse, a double contraception method
from the inclusion up to 3 months after the last dosing.

- Male subjects, who partners are pregnant, must use during sexual intercourse a condom
from inclusion to three months after the last dosing.

- Male subject has agreed not to donate sperm from the time of inclusion up to 3 months
after the last dosing.

Exclusion criteria:

- Any history or presence of clinically relevant disease at screening which could
interfere with the objectives of the study or the safety fo the subject's
participation.

- History of renal disease, or significantly abnormal kidney function test (glomerular
filtration rate [GFR]<90 mg/min as calculated using the Cockcroft-Gault equation) at
screening.

- Frequent headaches and/or migraines, recurrent nausea and/or vomiting.

- Blood donation of a pint or more within 2 months before inclusion.

- Symptomatic, postural hypotension, irrespective of the decrease in blood pressure, or
asymptomatic postural hypotension defined as a decrease in systolic blood pressure of
20 mmHg or more within 3 minutes when changing from supine to standing position.

- Presence or history of drug hypersensitivity, or allergic disease diagnosed and
treated by a physician.

- Any history of presence of deep vein thrombosis or pulmonary embolism or a recurrent
or frequent history of deep vein thrombosis in first degree relatives (parents,
siblings, or children).

- Any presence or history of urinary tract infection or genital mycotic infection in the
last 4 weeks before screening.

- History or presence of drug or alcohol abuse.

- Smoking more than 5 cigarettes or equivalent per day, unable to stop smoking during
the study.

- Excessive consumption of beverages containing xanthine bases (more than 4 cups or
glasses per day).

- If female, pregnancy (defined as positive beta-HCG) blood test if applicable)
breast-feeding.

- Any medication (including St John's Wort) within 14 days before inclusion or within 5
time the elimination half-life or pharmacodynamic half-life of the medication; any
vaccination within the last 28 days and any biologics (antibody or its derivatives)
given within 4 months before inclusion or within 5 terminal elimination half-life of
the biologic.

- Any subject in the exclusion period of a previous study according to applicable
regulations.

- Any subject who cannot be contracted in the case of an emergency.

The above information is not intended to contain all considerations relevant to a patient's
potential participation in a clinical trial.