BACKGROUND AND OBJECTIVE: The anti- @entity302 drug @entity4677 is excreted renally. The objective of this trial was to evaluate the pharmacokinetics of @entity4677 in Japanese @entity1 with @entity8 including @entity454 ( @entity454 ) to confirm that existing dosing instructions-based on data from European @entity1 -are appropriate in a Japanese population. METHODS: This was a nonrandomised, open-label trial. Six @entity1 were allocated to each of five groups (normal renal function, mild, moderate and severe @entity8 and @entity454 ); 30 @entity1 in total. @entity1 received a single dose of @entity4677 500  mg (normal or mild), 250  mg (moderate or severe), or 500  mg followed by 250  mg post-haemodialysis ( @entity454 ). Blood and urine samples were obtained serially for @entity4677 and metabolite determinations. Noncompartmental pharmacokinetic parameters were calculated and steady-state profiles were simulated using the superposition method. RESULTS: In this trial, @entity4677 total clearance decreased proportionally with @entity1011 clearance: 52, 31, 25, 20 and 11  mL/ @entity1009 .73  m(2) in healthy controls and in @entity1 with mild, moderate, severe @entity8 , and @entity454 , respectively. Simulated @entity4677 plasma profiles using the recommended dose adjustments were within the range for normal renal function. Overall, results from this trial were consistent with historical European data. CONCLUSION: These findings confirm that the dosing instructions are appropriate for Japanese @entity1 with @entity8 including @entity454 .

XXXX pharmacokinetics in Japanese subjects with @entity8 .

@entity1 :: ('9606', 'Species') :: ['participants', 'patients', 'Participants'] @entity4677 :: ('MESH:C026098', 'Chemical') :: ['levetiracetam'] @entity8 :: ('MESH:D007674', 'Disease') :: ['renal impairment'] @entity1009 :: ('966', 'Gene') :: ['min/1'] @entity302 :: ('MESH:D004827', 'Disease') :: ['epileptic'] @entity1011 :: ('MESH:D003404', 'Chemical') :: ['creatinine'] @entity454 :: ('MESH:D007676', 'Disease') :: ['end-stage renal disease', 'ESRD']
@entity4677 :: (MESH:C026098,Chemical) :: ['Levetiracetam']
