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KMID : 1038020230310040226
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Translational and Clinical Pharmacology
2023 Volume.31 No. 4 p.226 ~ p.237
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Pharmacokinetic properties of a new sustained-release pregabalin tablet in subjects with reduced renal function
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Park Maria
Choi Sue-In
Han Sung-Pil
Shin Won-Suk
Kim An-Hye
Han Seung-Hoon
Kim Bo-Min
LimYe-Ji
Yoo Hyoung-Gyoon
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Abstract
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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]) for maximum concentration (Cmax), and area under the concentration-time profile from 0 to the last measurable time (AUClast) after Y75T of Cohort B to those of Y75T of Cohort A were 1.2273 (1.0245?1.4701), and 2.4146 (1.8142?3.2138), respectively. The GMR (90% CI) for Cmax, and AUClast after Y75T of Cohort B to those of Y150T of Cohort A were 0.6476 (0.5229?0.8021), and 1.1471 (0.8418?1.5632), respectively. Simulated steady-steady pregabalin concentrations after once-daily Y75T dosing in subjects with eGFR 45 mL/min/1.73 m2 were within the range of steady-state concentrations simulated after once-daily Y150T dosing in subjects with eGFR 90 mL/min/1.73 m2. The total pregabalin exposure of Y75T in patients with moderate renal impairment was comparable with that of Y150T in subjects with near-normal renal function.
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KEYWORD
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Pharmacokinetics, Pregabalin, Delayed-Action Preparations, Renal Insufficiency
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