Effect of age and renal impairment on the pharmacokinetics and safety of trimetazidine: An open-label multiple-dose study
The result's identifiers
Result code in 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>
Result on the web
<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>
Alternative languages
Result language
angličtina
Original language name
Effect of age and renal impairment on the pharmacokinetics and safety of trimetazidine: An open-label multiple-dose study
Original language description
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.
Czech name
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Czech description
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Classification
Type
J<sub>imp</sub> - Article in a specialist periodical, which is included in the Web of Science database
CEP classification
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OECD FORD branch
30104 - Pharmacology and pharmacy
Result continuities
Project
—
Continuities
V - Vyzkumna aktivita podporovana z jinych verejnych zdroju
Others
Publication year
2020
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Data specific for result type
Name of the periodical
DRUG DEVELOPMENT RESEARCH
ISSN
0272-4391
e-ISSN
1098-2299
Volume of the periodical
81
Issue of the periodical within the volume
5
Country of publishing house
US - UNITED STATES
Number of pages
9
Pages from-to
564-572
UT code for WoS article
000554917000006
EID of the result in the Scopus database
2-s2.0-85081012752