Sotagliflozin Bioequivalence Study

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.