Matches in SemOpenAlex for { <https://semopenalex.org/work/W2790162016> ?p ?o ?g. }
Showing items 1 to 88 of
88
with 100 items per page.
- W2790162016 endingPage "822" @default.
- W2790162016 startingPage "814" @default.
- W2790162016 abstract "Abstract Delafloxacin, a fluoroquinolone, has activity against Gram‐positive organisms including methicillin‐resistant S aureus and fluoroquinolone‐susceptible and ‐resistant Gram‐negative organisms. The intravenous formulation of delafloxacin contains the excipient sulfobutylether‐β‐cyclodextrin (SBECD), which is eliminated by renal filtration. This study examined the pharmacokinetics and safety of SBECD after single intravenous (IV) infusions in subjects with renal impairment. The study was an open‐label, parallel‐group, crossover study in subjects with normal renal function or mild, moderate, or severe renal impairment, and those with end‐stage renal disease undergoing hemodialysis. Subjects received 300 mg delafloxacin IV or placebo IV, containing 2400 mg SBECD, in 2 periods separated by ≥14‐day washouts. SBECD total clearance decreased with decreasing renal function, with a corresponding increase in area under the concentration‐time curve (AUC 0‐∞ ). After IV delafloxacin 300 mg administration, SBECD mean total clearance was 6.28 and 1.24 L/h, mean AUC 0‐∞ was 387 and 2130 h·μg/mL, and mean renal clearance was 5.36 and 1.14 L/h in normal and severe renal subjects, respectively. Similar values were obtained after IV placebo administration. In subjects with end‐stage renal disease, delafloxacin 300 mg IV produced mean SBECD AUC 0‐48 values of 2715 and 7861 h·μg/mL when dosed before and after hemodialysis, respectively. Total SBECD clearance exhibited linear relationships to estimated glomerular filtration rate and creatinine clearance. Single doses of IV delafloxacin 300 mg and IV placebo were well tolerated in all groups. In conclusion, decreasing renal function causes reduced SBECD clearance and increased exposures, but SBECD continues to exhibit a good safety and tolerability profile in IV formulations." @default.
- W2790162016 created "2018-03-29" @default.
- W2790162016 creator A5000569581 @default.
- W2790162016 creator A5002741035 @default.
- W2790162016 creator A5019629197 @default.
- W2790162016 creator A5029974599 @default.
- W2790162016 creator A5047824873 @default.
- W2790162016 creator A5079459927 @default.
- W2790162016 creator A5083400010 @default.
- W2790162016 date "2018-03-26" @default.
- W2790162016 modified "2023-09-27" @default.
- W2790162016 title "Clinical Pharmacokinetics of Sulfobutylether‐β‐Cyclodextrin in Patients With Varying Degrees of Renal Impairment" @default.
- W2790162016 cites W1550111394 @default.
- W2790162016 cites W2020520992 @default.
- W2790162016 cites W2033144166 @default.
- W2790162016 cites W2055864845 @default.
- W2790162016 cites W2099664779 @default.
- W2790162016 cites W2114171934 @default.
- W2790162016 cites W2115007775 @default.
- W2790162016 cites W2116260433 @default.
- W2790162016 cites W2779328533 @default.
- W2790162016 doi "https://doi.org/10.1002/jcph.1077" @default.
- W2790162016 hasPubMedCentralId "https://www.ncbi.nlm.nih.gov/pmc/articles/6718009" @default.
- W2790162016 hasPubMedId "https://pubmed.ncbi.nlm.nih.gov/29578585" @default.
- W2790162016 hasPublicationYear "2018" @default.
- W2790162016 type Work @default.
- W2790162016 sameAs 2790162016 @default.
- W2790162016 citedByCount "25" @default.
- W2790162016 countsByYear W27901620162018 @default.
- W2790162016 countsByYear W27901620162020 @default.
- W2790162016 countsByYear W27901620162021 @default.
- W2790162016 countsByYear W27901620162022 @default.
- W2790162016 countsByYear W27901620162023 @default.
- W2790162016 crossrefType "journal-article" @default.
- W2790162016 hasAuthorship W2790162016A5000569581 @default.
- W2790162016 hasAuthorship W2790162016A5002741035 @default.
- W2790162016 hasAuthorship W2790162016A5019629197 @default.
- W2790162016 hasAuthorship W2790162016A5029974599 @default.
- W2790162016 hasAuthorship W2790162016A5047824873 @default.
- W2790162016 hasAuthorship W2790162016A5079459927 @default.
- W2790162016 hasAuthorship W2790162016A5083400010 @default.
- W2790162016 hasBestOaLocation W27901620161 @default.
- W2790162016 hasConcept C112705442 @default.
- W2790162016 hasConcept C126322002 @default.
- W2790162016 hasConcept C126894567 @default.
- W2790162016 hasConcept C142724271 @default.
- W2790162016 hasConcept C159641895 @default.
- W2790162016 hasConcept C204787440 @default.
- W2790162016 hasConcept C27081682 @default.
- W2790162016 hasConcept C2778063415 @default.
- W2790162016 hasConcept C3019040382 @default.
- W2790162016 hasConcept C71924100 @default.
- W2790162016 hasConcept C98274493 @default.
- W2790162016 hasConceptScore W2790162016C112705442 @default.
- W2790162016 hasConceptScore W2790162016C126322002 @default.
- W2790162016 hasConceptScore W2790162016C126894567 @default.
- W2790162016 hasConceptScore W2790162016C142724271 @default.
- W2790162016 hasConceptScore W2790162016C159641895 @default.
- W2790162016 hasConceptScore W2790162016C204787440 @default.
- W2790162016 hasConceptScore W2790162016C27081682 @default.
- W2790162016 hasConceptScore W2790162016C2778063415 @default.
- W2790162016 hasConceptScore W2790162016C3019040382 @default.
- W2790162016 hasConceptScore W2790162016C71924100 @default.
- W2790162016 hasConceptScore W2790162016C98274493 @default.
- W2790162016 hasIssue "6" @default.
- W2790162016 hasLocation W27901620161 @default.
- W2790162016 hasLocation W27901620162 @default.
- W2790162016 hasLocation W27901620163 @default.
- W2790162016 hasLocation W27901620164 @default.
- W2790162016 hasOpenAccess W2790162016 @default.
- W2790162016 hasPrimaryLocation W27901620161 @default.
- W2790162016 hasRelatedWork W127748368 @default.
- W2790162016 hasRelatedWork W2063122013 @default.
- W2790162016 hasRelatedWork W2065026575 @default.
- W2790162016 hasRelatedWork W2066161543 @default.
- W2790162016 hasRelatedWork W2149162188 @default.
- W2790162016 hasRelatedWork W2276955175 @default.
- W2790162016 hasRelatedWork W2374153524 @default.
- W2790162016 hasRelatedWork W2400700397 @default.
- W2790162016 hasRelatedWork W4226471102 @default.
- W2790162016 hasRelatedWork W86176808 @default.
- W2790162016 hasVolume "58" @default.
- W2790162016 isParatext "false" @default.
- W2790162016 isRetracted "false" @default.
- W2790162016 magId "2790162016" @default.
- W2790162016 workType "article" @default.