Bioequivalence Study of Vigabatrin ORPHELIA Pharma 500mg Soluble Tablets and SabrilTM 500mg Granules for Oral Administration

Exclusion Criteria

• •1. Any history or presence of cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic, haematological, neurologic, psychiatric, systemic, infectious disease or psychiatric disorders;
• •2. Frequent headaches and / or migraine, recurrent nausea and / or vomiting;
• •3. History of abnormal vision (e.g. reduced visual field, retinopathy, etc…);
• •4. Abnormal visual field recorded during the inclusion period;
• •5. Evidence of any clinically significant acute or chronic disease;
• •6. Symptomatic hypotension whatever the decrease of blood pressure or asymptomatic postural hypotension defined by a decrease in SBP or DBP equal to or greater than 20 mmHg within two minutes when changing from the supine to the standing position;
• •7. Surgery or blood donation (including in the frame of a clinical trial) within 2 months before administration;
• •8. General anaesthesia within 3 months before administration;
• •9. Presence or history of drug hypersensitivity, asthma or allergic disease diagnosed and treated by a physician;
• •10. Inability to abstain from intensive muscular effort;
• •11. No possibility of contact in case of emergency;
• •12. Any drug intake (except paracetamol or contraception) during the last month prior to the first administration;
• •13. History or presence of drug or alcohol abuse (alcohol consumption \> 40 grams / day);
• •14. Excessive consumption of beverages containing xanthine bases (\> 4 cups or glasses / day);
• •15. Positive Hepatitis B surface (HBs) antigen or anti Hepatitis C Virus (HCV) antibody (not including HSV), or positive results for Human Immunodeficiency Virus (HIV) 1 or 2 tests;
• •16. Positive results of screening for drugs of abuse;
• •17. Subject who, in the judgment of the Investigator, was likely to be non-compliant or uncooperative during the study, or unable to cooperate because of a language problem, poor mental development;
• •18. Exclusion period of a previous study;
• •19. Administrative or legal supervision;
• •20. Subject who would receive more than 4500 euros as indemnities for his participation in biomedical research within the 12 last months, including the indemnities for the present study