A Bioequivalence Study Testing Two Formulations of Sotagliflozin in Healthy Male and Female Subjects Under Fasted Conditions

Exclusion Criteria

• •Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal (especially pancreatitis), hepatic (especially biliary disease, including cholecystectomy), renal, metabolic, hematological, neurological, musculoskeletal, articular, psychiatric, systemic, ocular, gynecologic (if female), or infectious disease, or signs of acute illness.
• •History of renal disease, or significantly abnormal kidney function test (glomerular filtration rate (GFR) \<90 mL/min as calculated using the Cockcroft-Gault equation (7) at screening.
• •Frequent headaches and/or migraine, recurrent nausea and/or vomiting (more than twice a month).
• •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 ≥20 mmHg 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.
• •History or presence of drug or alcohol abuse (alcohol consumption more than 40 g per day on a regular basis).
• •Smoking more than 5 cigarettes or equivalent per day and/or 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 human chorionic gonadotropin (β-HCG blood test), breast-feeding.
• •Any medication (over-the counter or prescription medications, including St John's Wort), or any herbal supplements or supra-therapeutic vitamins within 14 days before inclusion or within 5 times the elimination half-life or pharmacodynamic half-life of the substance; any vaccination within the last 28 days, and any biologics (antibody or its derivatives) given within 4 months before inclusion.
• •Any subject who, in the judgment of the Investigator, is likely to be noncompliant during the study, or unable to cooperate because of a language problem or poor mental development.
• •Any subject in the exclusion period of a previous study according to applicable regulations.
• •Any subject who cannot be contacted in case of emergency.
• •Any subject who is the Investigator or any sub-investigator, research assistant, pharmacist, study coordinator, or other staff thereof, directly involved in conducting the study.
• •Positive result on any of the following tests: hepatitis B surface (HBs Ag) antigen, anti hepatitis C virus antibodies, anti-human immunodeficiency virus 1 and 2 antibodies (anti HIV1 and anti HIV2 Ab).
• •Positive result on urine drug screen (amphetamines/methamphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates).
• •Positive alcohol test.
• •Any consumption of citrus (grapefruit, orange, etc) or their juices within 5 days before inclusion.
• •Any history or presence of deep leg 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.
• •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.