Pharmacokinetic properties of a new sustained-release pregabalin tablet in subjects with reduced renal function.

ABSTRACT: A new sustained-release (SR) pregabalin tablet, YHD1119, was formulated for once-daily dosing. In the current study, we aimed to evaluate the pharmacokinetics of YHD1119 tablets in patients with reduced renal function. Subjects were grouped by creatinine clearance: > 60 mL/min/1.73m² (Cohort A) and 30-60 mL/min/1.73m² (Cohort B). Eight subjects in Cohort A received a YHD1119 75 mg tablet (Y75T) and a YHD1119 150 mg tablet (Y150T) in each period, and eight subjects in Cohort B received a Y75T. Non-compartment analysis and population pharmacokinetic analysis using a one-compartment model with first-order elimination and first-order absorption with lag time were performed. Sixteen subjects completed the study. The geometric mean ratio (GMR) (90% confidence intervals [CI]

SUBMITTER: Park M 

PROVIDER: S-EPMC10772055 | biostudies-literature | 2023 Dec

REPOSITORIES: biostudies-literature