Nabumetone and 6-MNA pharmacokinetics, assessment of intrasubject variability and gender effect

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216208%3A11110%2F16%3A10286463" target="_blank" >RIV/00216208:11110/16:10286463 - isvavai.cz</a>

Nalezeny alternativní kódy

RIV/00216208:11310/16:10286463

Výsledek na webu

<a href="http://dx.doi.org/10.1097/MJT.0000000000000158" target="_blank" >http://dx.doi.org/10.1097/MJT.0000000000000158</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1097/MJT.0000000000000158" target="_blank" >10.1097/MJT.0000000000000158</a>

Jazyk výsledku

angličtina

Název v původním jazyce

Nabumetone and 6-MNA pharmacokinetics, assessment of intrasubject variability and gender effect

Popis výsledku v původním jazyce

In this study we describe pharmacokinetics (PK) of nabumetone, which has been previously studied mainly indirectly using its active metabolite. Since the 6-MNA pharmacokinetics suggests that nabumetone belongs to group of highly variable drugs (HVD), we have also evaluatedits intra- and inter- subject variability.We have developed and validated a rapid and sensitive HPLC-UV analytic method for analysis of both nabumetone and 6-MNA. Results show that nabumetone reaches cmax with an average (+-SD) value of 0.5552 +- 0.2021 mg.l-1 at mean tmax of 8.63 +- 7.05 h, with mean AUClast of 18.069 +- 7.190 h.mg.l-1. There were no statistically significant differences between both sexes in PK of nabumetone, however for 6-MNA the mean +- SD AUClast was higher in men than in women with mean respective values of 721.2342 +- 185.5272 h.mg.l-1 and 545.2733 +- 97.6902 h.mg.l-1(p = 0.013), and clearance was lower in men 0.6536 +- 0.2177 l.h-1 in comparison with women 0.8760 +- 0.1751 l.h-1(p = 0.019).Inter-subject variability of nabumetone and 6-MNA was found to be between 35-45% and 10-30% for all assessed parameters (AUClast, cmax, partial AUCs), respectively. The intra-subject variability was only modest, 15.59% and 6.40 % for AUClast for nabumetone and 6-MNA, respectively. The respective values of intra-subject variability for cmax were 13.66 % and 5.42 %.

Název v anglickém jazyce

Nabumetone and 6-MNA pharmacokinetics, assessment of intrasubject variability and gender effect

Popis výsledku anglicky

In this study we describe pharmacokinetics (PK) of nabumetone, which has been previously studied mainly indirectly using its active metabolite. Since the 6-MNA pharmacokinetics suggests that nabumetone belongs to group of highly variable drugs (HVD), we have also evaluatedits intra- and inter- subject variability.We have developed and validated a rapid and sensitive HPLC-UV analytic method for analysis of both nabumetone and 6-MNA. Results show that nabumetone reaches cmax with an average (+-SD) value of 0.5552 +- 0.2021 mg.l-1 at mean tmax of 8.63 +- 7.05 h, with mean AUClast of 18.069 +- 7.190 h.mg.l-1. There were no statistically significant differences between both sexes in PK of nabumetone, however for 6-MNA the mean +- SD AUClast was higher in men than in women with mean respective values of 721.2342 +- 185.5272 h.mg.l-1 and 545.2733 +- 97.6902 h.mg.l-1(p = 0.013), and clearance was lower in men 0.6536 +- 0.2177 l.h-1 in comparison with women 0.8760 +- 0.1751 l.h-1(p = 0.019).Inter-subject variability of nabumetone and 6-MNA was found to be between 35-45% and 10-30% for all assessed parameters (AUClast, cmax, partial AUCs), respectively. The intra-subject variability was only modest, 15.59% and 6.40 % for AUClast for nabumetone and 6-MNA, respectively. The respective values of intra-subject variability for cmax were 13.66 % and 5.42 %.

Druh

J_x - Nezařazeno - Článek v odborném periodiku (Jimp, Jsc a Jost)

CEP obor

FR - Farmakologie a lékárnická chemie

OECD FORD obor

—

Projekt

—

Návaznosti

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Rok uplatnění

2016

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

American Journal of Therapeutics

ISSN

1075-2765

e-ISSN

—

Svazek periodika

23

Číslo periodika v rámci svazku

6

Stát vydavatele periodika

US - Spojené státy americké

Počet stran výsledku

6

Strana od-do

"e1498"-"e1503"

Kód UT WoS článku

000388699800032

EID výsledku v databázi Scopus

2-s2.0-84912019918