Bioavailability of Stiripentol After Single Oral Dose of Capsule vs Suspension in Healthy Subjects (STILIQ)

Exclusion Criteria

• •Unsuitable veins for repeated venipuncture.
• •Relevant history/presence of cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, psychiatric, systemic, or infectious disease.
• •Evidence of any clinically significant acute or chronic disease.
• •History of suicidal ideation or suicide attempt.
• •Surgery (including clinical trial procedures) within 2 months before dosing.
• •Blood donation within 2 months before dosing.
• •History/presence of drug hypersensitivity, asthma, or allergy.
• •Known hypersensitivity to study materials or related compounds.
• •Inability/difficulty swallowing capsules.
• •No possibility of emergency contact.
• •Any drug intake (except paracetamol) within 4 weeks prior to dosing or \< 5 half-lives (whichever longer). Prohibited: carbamazepine, phenytoin, phenobarbital, CYP enzyme modulators.
• •Use of herbal products affecting CYP enzymes within 2 weeks or \< 5 half-lives before dosing.
• •Special diets (vegetarian, vegan, gluten-free).
• •Vigorous exercise from 4 days before dosing until post-study assessments.
• •Pregnant or breastfeeding women.
• •Drug/alcohol abuse history, daily alcohol intake \> 4 drinks, or positive alcohol test.
• •Excessive xanthine beverages (\> 5 cups/day).
• •Nicotine use \> 5 cigarettes/day or inability to abstain 48h before and during study.
• •Intake of grapefruit/Seville oranges/poppy seed or other CYP modulators 1 week before dosing and during study.
• •Intake of methylxanthines (coffee, tea, cola, cocoa, mate, guarana, chocolate) or quinine (e.g., tonic water) from 48h before dosing and during study.
• •Unable/unwilling to follow diet requirements (see protocol section 10.7).
• •Positive test for HBsAg, HCV antibody, or HIV 1/2.
• •Positive drug screen.
• •Significant biological or clinical abnormalities judged incompatible with study.
• •Participation in another interventional trial during exclusion period or investigational product within last 60 days or \< 5 half-lives.
• •Under guardianship, curatorship, or deprived of liberty.
• •Under Court protection.
• •Would exceed €6000 compensation for biomedical research in last 12 months (including this study).
• •Health status not allowing provision of informed consent.