التفاصيل البيبلوغرافية
| العنوان: |
Pharmacokinetic properties of a new sustained-release pregabalin tablet in subjects with reduced renal function. |
| المؤلفون: |
Park, Maria, Suein Choi, Sungpil Han, Wonsuk Shin, Anhye Kim, Seunghoon Han, Bomin Kim, Yeji Lim, Hyounggyoon Yoo |
| المصدر: |
Translational & Clinical Pharmacology; Dec2023, Vol. 31 Issue 4, p226-237, 12p |
| مصطلحات موضوعية: |
KIDNEY physiology, PREGABALIN, PHARMACOKINETICS, CONTROLLED release preparations, CONFIDENCE intervals |
| مستخلص: |
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. [ABSTRACT FROM AUTHOR] |
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| قاعدة البيانات: |
Complementary Index |
