| Outcome Measures: |
Primary: Area under the plasma concentration versus time curve, Area under the plasma concentration versus time curve: AUC0-12 (corresponding to AUC0-tau), in order to assess the need of dose adjustment in the renal impaired population., Steady state at Day15|Peak Plasma Concentration, Peak Plasma Concentration: Cmax in order to assess the need of dose adjustment in the renal impaired population., Steady state at Day15 | Secondary: Peak Plasma Concentration, for stiripentol in plasma, Peak Plasma Concentration : Cmax on Day 1, Day 1 and Day 15 when applicable|The area under the concentration-time curve from time zero (pre-dose) to 12 h post-dose, for stiripentol in plasma, The area under the concentration-time curve from time zero (pre-dose) to 12 h post-dose: AUC0-12 corresponds to AUC0-tau on Day 15): AUC0-12 on Day 1, Day 1 and Day 15 when applicable|The time at which Cmax is apparent, for stiripentol in plasma, The time at which Cmax is apparent: tmax, Day 1 and Day 15 when applicable|The area under the concentration-time curve from time zero (pre-dose) to 24 h post-dose, for stiripentol in plasma, The area under the concentration-time curve from time zero (pre-dose) to 24 h post-dose: AUC0-24,, Day 1 and Day 15 when applicable|The area under the concentration-time from time zero (pre-dose) to the time of last quantifiable concentration, for stiripentol in plasma, The area under the concentration-time from time zero (pre-dose) to the time of last quantifiable concentration: AUC0-t, Day 1 and Day 15 when applicable|The apparent terminal elimination half-life, for stiripentol in plasma, The apparent terminal elimination half-life t1/2, Day 1 and Day 15 when applicable|Apparent total clearance at steady-state, for stiripentol in plasma, Apparent total clearance at steady-state: CLss/F, Day 1 and Day 15 when applicable|Fraction unbound (stiripentol) in plasma defined as unbound concentration/total concentration (on Day 15 only), for stiripentol in plasma, Fraction unbound (stiripentol) in plasma defined as unbound concentration/total concentration (on Day 15 only) : Fu, Day 1 and Day 15 when applicable|Pre-morning dose concentration, for stiripentol in plasma, Pre-morning dose concentration : Cmin, Day 1 and Day 15 when applicable|Accumulation ratio evaluated, for stiripentol in plasma, Accumulation ratio evaluated: Racc, Day 1 and Day 15 when applicable|Total amount excreted over the time interval between 0 and 12 h, for stiripentol in urine, Total amount excreted over the time interval between 0 and 12 h : Ae0-12, Day 1 and Day 15 when applicable|Total amount excreted over the total time interval of urine collection i.e. ]0 - 24] h, for stiripentol in urine, Total amount excreted over the total time interval of urine collection i.e. \]0 - 24\] h : Ae0-24, Day 1 and Day 15 when applicable|The fraction of the dose excreted in urine over the total time interval of urine collection i.e. ]0 - 24] h, for stiripentol in urine, The fraction of the dose excreted in urine over the total time interval of urine collection i.e. \]0 - 24\] h : fe0-24, Day 1 and Day 15 when applicable|The renal clearance, for stiripentol in urine, The renal clearance : CLr, Day 1 and Day 15 when applicable|Peak Plasma Concentration, for stiripentol relevant metabolites in plasma, Peak Plasma Concentration : Cmax, Day 1 and Day 15 when applicable|The time at which Cmax is apparent, for stiripentol relevant metabolites in plasma, Peak Plasma Concentration : Cmax, Day 1 and Day 15 when applicable|The area under the concentration-time curve from time zero (pre-dose) to 12 h post-dose: AUC0-12 corresponds to AUC0-tau on Day 15), for stiripentol relevant metabolites in plasma, The area under the concentration-time curve from time zero (pre-dose) to 12 h post-dose: AUC0-12 corresponds to AUC0-tau on Day 15) : AUC0-12,, Day 1 and Day 15 when applicable|The area under the concentration-time curve from time zero (pre-dose) to 24 h post-dose, for stiripentol relevant metabolites in plasma, The area under the concentration-time curve from time zero (pre-dose) to 24 h post-dose: AUC0-24,, Day 1 and Day 15 when applicable|The area under the concentration-time from time zero (pre-dose) to the time of last quantifiable concentration, for stiripentol relevant metabolites in plasma, The area under the concentration-time from time zero (pre-dose) to the time of last quantifiable concentration: AUC0-t,, Day 1 and Day 15 when applicable|The apparent terminal elimination half-life, for stiripentol relevant metabolites in plasma, The apparent terminal elimination half-life : t1/2,, Day 1 and Day 15 when applicable|Pre-morning dose concentration, for stiripentol relevant metabolites in plasma, Pre-morning dose concentration : Cmin., Day 1 and Day 15 when applicable|Total amount excreted over the time interval between 0 and 12 h, for stiripentol relevant metabolites in urine, Total amount excreted over the time interval between 0 and 12 h : Ae0-12, Day 1 and Day 15 when applicable|Total amount excreted over the total time interval of urine collection i.e. ]0 - 24] h, for stiripentol relevant metabolites in urine, Total amount excreted over the total time interval of urine collection i.e. \]0 - 24\] h : Ae0-24, Day 1 and Day 15 when applicable|The fraction of the dose excreted in urine over the total time interval of urine collection i.e. ]0 - 24] h, for stiripentol relevant metabolites in urine, The fraction of the dose excreted in urine over the total time interval of urine collection i.e. \]0 - 24\] h : fe0-24, Day 1 and Day 15 when applicable|The renal clearance, for stiripentol relevant metabolites in urine, The renal clearance : CLr, Day 1 and Day 15 when applicable
|
