Effect of age and renal impairment on the pharmacokinetics and safety of trimetazidine: An open-label multiple-dose study
Jazyk angličtina Země Spojené státy americké Médium print-electronic
Typ dokumentu klinické zkoušky kontrolované, časopisecké články, multicentrická studie, práce podpořená grantem
Grantová podpora
This study was funded by a consortium of Companies including Actavis Group PTC ehf., Alvogen IPCo S.a.r.l., Chemical Works of Gedeon Richter Plc., Generis Farmacêutica, S.A., Lek Pharmaceuticals d.d. (Sandoz Group), Labesfal Genéricos S.A., Laboratorios Cinfa, S.A., Lupin (Europe) Limited, Mylan S.A.S., and Teva Pharmaceuticals Europe B.V. - International
PubMed
32128844
DOI
10.1002/ddr.21654
Knihovny.cz E-zdroje
- Klíčová slova
- age, pharmacokinetics, renal-impairment, safety, tolerability, trimetazidine,
- MeSH
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- renální insuficience krev metabolismus MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- trimetazidin škodlivé účinky krev farmakokinetika MeSH
- vazodilatancia škodlivé účinky krev farmakokinetika MeSH
- věkové faktory MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky kontrolované MeSH
- multicentrická studie MeSH
- práce podpořená grantem MeSH
- Názvy látek
- trimetazidin MeSH
- vazodilatancia MeSH
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 Cmax,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 Cmax,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 Cmax,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 Cmax,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 Cmax,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.
Department of Clinical Research Gedeon Richter Plc Budapest Hungary
Department of Clinical Research Generis Farmacêutica S A Amadora Portugal
Department of Drug Safety and Risk Management Lupin Limited Mumbai India
Department of Global Clinical Sciences Mylan Amstelveen The Netherlands
Department of Medicine Comac Medical Sofia Bulgaria
Department of Medicine Thomayer Hospital Prague Czech Republic
Department of Pharmacoepidemiology Teva Pharmaceutical Industries Ltd Petach Tikva Israel
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