Effect of age and renal impairment on the pharmacokinetics and safety of trimetazidine: An open-label multiple-dose study
Identifikátory výsledku
Kód výsledku v IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00064190%3A_____%2F20%3AN0000051" target="_blank" >RIV/00064190:_____/20:N0000051 - isvavai.cz</a>
Výsledek na webu
<a href="http://dx.doi.org/10.1002/ddr.21654" target="_blank" >http://dx.doi.org/10.1002/ddr.21654</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.1002/ddr.21654" target="_blank" >10.1002/ddr.21654</a>
Alternativní jazyky
Jazyk výsledku
angličtina
Název v původním jazyce
Effect of age and renal impairment on the pharmacokinetics and safety of trimetazidine: An open-label multiple-dose study
Popis výsledku v původním jazyce
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-tau)ss)was 112.2 (90% CI; 92.0-136.8) andC(max,ss)was 109.9 (89.6-134.8), Group 3 and 1 of AUC((0-tau),ss)was 140.5 (115.9-170.3) andC(max,ss)was 137.8 (112.9-168.2), Group 4 and 1 of AUC((0-tau),ss)was 114.2 (90.3-144.4) andC(max,ss)was 120.8 (92.5-157.8), Group 5 and 1 of; AUC((0-tau),ss)was 213.0 (153.1-296.3) andC(max,ss)was 123.3 (92.2-164.7) and Group 6 and 1 of AUC((0-tau),ss)was 247.4 (197.8-309.6) andC(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.
Název v anglickém jazyce
Effect of age and renal impairment on the pharmacokinetics and safety of trimetazidine: An open-label multiple-dose study
Popis výsledku anglicky
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-tau)ss)was 112.2 (90% CI; 92.0-136.8) andC(max,ss)was 109.9 (89.6-134.8), Group 3 and 1 of AUC((0-tau),ss)was 140.5 (115.9-170.3) andC(max,ss)was 137.8 (112.9-168.2), Group 4 and 1 of AUC((0-tau),ss)was 114.2 (90.3-144.4) andC(max,ss)was 120.8 (92.5-157.8), Group 5 and 1 of; AUC((0-tau),ss)was 213.0 (153.1-296.3) andC(max,ss)was 123.3 (92.2-164.7) and Group 6 and 1 of AUC((0-tau),ss)was 247.4 (197.8-309.6) andC(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.
Klasifikace
Druh
J<sub>imp</sub> - Článek v periodiku v databázi Web of Science
CEP obor
—
OECD FORD obor
30104 - Pharmacology and pharmacy
Návaznosti výsledku
Projekt
—
Návaznosti
V - Vyzkumna aktivita podporovana z jinych verejnych zdroju
Ostatní
Rok uplatnění
2020
Kód důvěrnosti údajů
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Údaje specifické pro druh výsledku
Název periodika
DRUG DEVELOPMENT RESEARCH
ISSN
0272-4391
e-ISSN
1098-2299
Svazek periodika
81
Číslo periodika v rámci svazku
5
Stát vydavatele periodika
US - Spojené státy americké
Počet stran výsledku
9
Strana od-do
564-572
Kód UT WoS článku
000554917000006
EID výsledku v databázi Scopus
2-s2.0-85081012752