Pharmacokinetic Comparison of Vonafexor Acid and Its Lysine Salt and Evaluation of Potential Drug-Drug Interactions

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.