Pharmacokinetic Parameters of Stiripentol in Renal Impaired Patients and Matching Controls With Normal Renal Function

Exclusion criteria

• . Unsuitable veins for repeated venipuncture,
• . Positive Hepatitis B surface (HBsAg) antigen or positive Hepatitis C Virus (HCV), or positive results for Human Immunodeficiency Virus (HIV)-1 or 2 tests,
• . History or presence of drug or alcohol abuse (alcohol consumption \>40 grams/day),
• . Subject/Patient 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,
• . Subject/Patient who cannot be contacted in case of emergency,
• . History or presence of allergy or unusual reactions to some drugs or anesthetics or known hypersensitivity to the investigation product or its excipients (including lactose intolerance), test material or related compound,
• . Who receive a medication known to affect both cyochromes (CYP) CYP1A2, CYP3A4, and CYP2C19, such as rifampin, within 1 month prior to the first dose administration. Concomitant use of medications known to strongly affect either CYP1A2, CYP3A4, or CYP2C19, such as phenytoin, phenobarbital or carbamazepine, should be avoided within 1 month prior to the first dose administration.
• . Subject/Patient who is in the exclusion period of a previous study,