Clinical Research Directory

Inclusion Criteria: * Healthy male or female subject, aged 18-65 years inclusive. * Females of childbearing potential: commitment to use a highly effective method of birth control which result in a low failure rate. Females of non-childbearing potential: either at least 3 months surgically sterilized or at least 1-year postmenopausal confirmed by the follicle stimulating hormone (FSH) level. Males: commitment to use an adequate contraceptive method consistently and correctly. * Negative pregnancy test for childbearing potential women or FSH ≥ 40 IU/mL for postmenopausal women. * Non-smoker subject or smoker of maximum 5 cigarettes a day and able to stop during the study. * Body Mass Index (BMI) between 18 and 30 kg/m2 inclusive. * Considered as healthy after a comprehensive clinical assessment (detailed medical history and complete physical examination). * Normal Blood Pressure and Heart Rate. * Normal ECG recording on a 12-lead ECG. * Laboratory parameters within the normal range of the laboratory (hematology, hemostasis, blood chemistry tests, urinalysis). * Normal dietary habits. * Signing a written informed consent prior to selection. * Covered by Health Insurance System and / or in compliance with the recommendations of National Law in force relating to biomedical research. Exclusion Criteria: * Any relevant history or presence of cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic, haematological, neurologic, psychiatric, systemic or infectious disease. * Frequent headaches and / or migraine, recurrent nausea and / or vomiting. * Symptomatic hypotension whatever the decrease of blood pressure or asymptomatic postural hypotension. * Blood donation in the 2 months before administration. * General anaesthesia in the 3 months before administration. * Presence or history of drug allergic condition and/or hypersensitivity. * Inability to abstain from intense muscular effort. * Any drug intake (except paracetamol and contraceptives) during the month prior to the first administration. * History or presence of drug or alcohol abuse (alcohol consumption \> 40 grams / day). * Excessive consumption of beverages with xanthine bases (\> 4 cups or glasses / day). * Positive Hepatitis B surface antigen or anti Hepatitis C Virus antibody, or positive results for Human Immunodeficiency Virus 1 or 2 tests. * Positive results for drugs of abuse tests. * No possibility of contact subject in case of emergency. * Subject who, in the judgment of the Investigator, is likely to be non-compliant or uncooperative during the study, or unable to cooperate because of a language problem, poor mental development. * Exclusion period of a previous study. * Administrative or legal supervision. * Subject who would receive more than 6'000 euros as indemnities for his participation in biomedical research within the 12 last months, including the indemnities for the present study.