In:
Drug Development Research, Wiley, Vol. 81, No. 5 ( 2020-08), p. 564-572
Kurzfassung:
This study evaluated the effect of age and renal impairment on pharmacokinetics of trimetazidine (TMZ) in healthy elderly and renally impaired subjects and assess safety and tolerability. In this open‐label, multi‐dose study, 73 subjects were divided into six treatment groups: (1) 55–65 years; (2) 66–75 years; (3) 〉 75 years (dosing for groups 1–3 [healthy]: B.D. for 4 days), (4) mild renally impaired (dosed B.D. for 8 days); (5) moderate renally impaired (dosed O.D. for 8 days); and (6) severe renally impaired‐no dialysis (dosed once every 48 h for 8 days). Blood and urine samples were collected and analyzed. The geometric least squares mean ratios for; Group 2 and 1 of AUC (0−τ)ss was 112.2 (90% CI; 92.0–136.8) and C max,ss was 109.9 (89.6–134.8), Group 3 and 1 of AUC (0−τ),ss was 140.5 (115.9–170.3) and C max,ss was 137.8 (112.9–168.2), Group 4 and 1 of AUC (0−τ),ss was 114.2 (90.3–144.4) and C max,ss was 120.8 (92.5–157.8), Group 5 and 1 of; AUC (0−τ),ss was 213.0 (153.1–296.3) and C max,ss was 123.3 (92.2–164.7) and Group 6 and 1 of AUC (0−τ),ss was 247.4 (197.8–309.6) and C max,ss was 95.6 (73.0–125.1). Significant increase in systemic exposure of TMZ was observed in subjects; over 75 year's age and renally impaired compared to healthy subjects. TMZ was safe and well‐tolerated.
Materialart:
Online-Ressource
ISSN:
0272-4391
,
1098-2299
Sprache:
Englisch
Verlag:
Wiley
Publikationsdatum:
2020
ZDB Id:
1500191-X
SSG:
15,3
