sotagliflozin bioequivalence study

Conditions: Type 2 Diabetes Mellitus

Summary: primary objective: to determine the bioequivalence of a single dose of the commercial tablet of sotagliflozin (test) compared to the development tablet of sotagliflozin (reference) under fasting conditions in healthy male and female subjects. secondary objectives: * to evaluate the single-dose pharmacokinetics of sotagliflozin and its main metabolite sotagliflozin 3-o-glucuronide following administration of a single sotagliflozin (test) tablet or a single sotagliflozin (reference) table in healthy male and female subjects under fasting conditions. * to evaluate safety and tolerability of a single dose sotagliflozin (test) tablet compared to a single sotagliflozin (reference) tablet administered under fasted conditions in healthy male and female subjects.

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.

Eligibility criteria:
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.