FRINK Linked Data Fragments server

Matches in SemOpenAlex for { <https://semopenalex.org/work/W2034008729> ?p ?o ?g. }

• W2034008729 endingPage "1053" @default.
• W2034008729 startingPage "1046" @default.
• W2034008729 abstract "Background: Existing formulations of recombinant human erythropoietin (rhEPO) in Korea contain human serum albumin. To avoid the potential risk of infection by human serum albumin, a new albumin-free rhEPO has been developed. Objective: This study was conducted to characterize and compare the pharmacokinetic and safety profiles and the bioequivalence of a newly developed albumin-free rhEPO (Aropotin® [TS Corporation, Seoul, South Korea]) with 2 existing rhEPO formulations (Espogen® [LG Life Sciences, Seoul, South Korea]; Recormon® [Roche, Basel, Switzerland]) with albumin in healthy Korean subjects. Methods: This was an open-label, randomized-sequence, 3-treatment, 3-way crossover study in which healthy, nonobese (±20% of ideal weight), male volunteers between the ages of 19 and 50 years were assigned to 1 of 2 dose levels (50 IU/kg or 100 IU/kg) of 3 formulations. Blood was collected over 32 hours and plasma rhEPO concentrations were determined using a validated enzyme immunoassay. There was a 14-day washout between periods. The pharmacoki-netic parameters of the 3 formulations were compared using the bioequivalence criteria of the US Food and Drug Administration, which requires that the 90% CIs of the geometric mean ratios for AUC0−t, AUC0−∞, and Cmax fall within 0.80 to 1.25. Tolerability was evaluated by physical examination with measurements of vital signs, clinical laboratory tests, and electrocardiogram. Subjects were followed up for 2 weeks after the last administration of study drug. Results: Twelve Korean male volunteers were enrolled and completed the study. Six subjects (mean [SD] age, 22.0 [1.7] years; weight, 63.3 [6.2] kg; height, 172.3 [3.5] cm) received a single 50 IU/kg IV bolus dose of study drug and the remaining 6 subjects (mean [SD] age, 23.7 [1.5] years; weight, 66.3 [4.8] kg; height, 174 [4.7] cm) received 100 IU/kg. After a single 50 IU/kg dose, the geometric mean ratio (90% CI) for Aropotin/Espogen was 1.04 (0.91–1.19) IU/L/h for AUC0−t and 1.02 (0.89–1.17) IU/L for Cmax. The geometric mean ratio (90% CI) for Aropotin/Recormon was 1.01 (0.88−1.15) IU/L/h for AUC0−t and 1.01 (0.89–1.16) IU/L for Cmax. After a single 100-IU/kg dose, the geometric mean ratio (90% CI) for Aropotin/ Espogen was 0.98 (0.86–1.13) IU/L/h for AUC0−t and 0.99 (0.87–1.13) IU/L for Cmax. The geometric mean ratio (90% CI) for Aropotin/Recormon was 0.99 (0.861.14) IU/L/h for AUC0−t and 0.96 (0.84–1.10) IU/L for Cmax. The most frequent adverse events (AEs) were 3 occurrences of elevated serum creatine phosphokinase and serum lactate dehydrogenase levels in the Recormon 100-IU/kg group (n = 3), 3 events of elevated serum lactate dehydrogenase levels in the Espogen 100-IU/kg group (n = 3), and 4 events of elevated serum total bilirubin levels in the Aropotin 100-IU/kg group (n = 3). All formulations were well tolerated with no serious AEs. Conclusion: The new formulation of rhEPO met the regulatory criteria for bioequivalence in these healthy Korean adult male volunteers. All formulations were generally well tolerated." @default.
• W2034008729 created "2016-06-24" @default.
• W2034008729 creator A5003763805 @default.
• W2034008729 creator A5007426315 @default.
• W2034008729 creator A5012863228 @default.
• W2034008729 creator A5058329575 @default.
• W2034008729 creator A5065283669 @default.
• W2034008729 creator A5077838016 @default.
• W2034008729 creator A5085479819 @default.
• W2034008729 date "2009-05-01" @default.
• W2034008729 modified "2023-10-16" @default.
• W2034008729 title "Pharmacokinetic, tolerability, and bioequivalence comparison of three different intravenous formulations of recombinant human erythropoietin in healthy Korean adult male volunteers: An open-label, randomized-sequence, three-treatment, three-way crossover study" @default.
• W2034008729 cites W1534550394 @default.
• W2034008729 cites W2011510235 @default.
• W2034008729 cites W2047000878 @default.
• W2034008729 cites W2058907838 @default.
• W2034008729 cites W2062043622 @default.
• W2034008729 cites W2140188175 @default.
• W2034008729 cites W2164808289 @default.
• W2034008729 cites W2278696640 @default.
• W2034008729 cites W2293458489 @default.
• W2034008729 cites W2336116827 @default.
• W2034008729 doi "https://doi.org/10.1016/j.clinthera.2009.05.013" @default.
• W2034008729 hasPubMedId "https://pubmed.ncbi.nlm.nih.gov/19539105" @default.
• W2034008729 hasPublicationYear "2009" @default.
• W2034008729 type Work @default.
• W2034008729 sameAs 2034008729 @default.
• W2034008729 citedByCount "12" @default.
• W2034008729 countsByYear W20340087292012 @default.
• W2034008729 countsByYear W20340087292014 @default.
• W2034008729 countsByYear W20340087292015 @default.
• W2034008729 countsByYear W20340087292016 @default.
• W2034008729 countsByYear W20340087292020 @default.
• W2034008729 crossrefType "journal-article" @default.
• W2034008729 hasAuthorship W2034008729A5003763805 @default.
• W2034008729 hasAuthorship W2034008729A5007426315 @default.
• W2034008729 hasAuthorship W2034008729A5012863228 @default.
• W2034008729 hasAuthorship W2034008729A5058329575 @default.
• W2034008729 hasAuthorship W2034008729A5065283669 @default.
• W2034008729 hasAuthorship W2034008729A5077838016 @default.
• W2034008729 hasAuthorship W2034008729A5085479819 @default.
• W2034008729 hasConcept C112705442 @default.
• W2034008729 hasConcept C126322002 @default.
• W2034008729 hasConcept C142724271 @default.
• W2034008729 hasConcept C197934379 @default.
• W2034008729 hasConcept C204787440 @default.
• W2034008729 hasConcept C22979827 @default.
• W2034008729 hasConcept C27081682 @default.
• W2034008729 hasConcept C2776768635 @default.
• W2034008729 hasConcept C2778375690 @default.
• W2034008729 hasConcept C2778534260 @default.
• W2034008729 hasConcept C42404028 @default.
• W2034008729 hasConcept C6557445 @default.
• W2034008729 hasConcept C71924100 @default.
• W2034008729 hasConcept C86803240 @default.
• W2034008729 hasConcept C87813604 @default.
• W2034008729 hasConcept C98274493 @default.
• W2034008729 hasConceptScore W2034008729C112705442 @default.
• W2034008729 hasConceptScore W2034008729C126322002 @default.
• W2034008729 hasConceptScore W2034008729C142724271 @default.
• W2034008729 hasConceptScore W2034008729C197934379 @default.
• W2034008729 hasConceptScore W2034008729C204787440 @default.
• W2034008729 hasConceptScore W2034008729C22979827 @default.
• W2034008729 hasConceptScore W2034008729C27081682 @default.
• W2034008729 hasConceptScore W2034008729C2776768635 @default.
• W2034008729 hasConceptScore W2034008729C2778375690 @default.
• W2034008729 hasConceptScore W2034008729C2778534260 @default.
• W2034008729 hasConceptScore W2034008729C42404028 @default.
• W2034008729 hasConceptScore W2034008729C6557445 @default.
• W2034008729 hasConceptScore W2034008729C71924100 @default.
• W2034008729 hasConceptScore W2034008729C86803240 @default.
• W2034008729 hasConceptScore W2034008729C87813604 @default.
• W2034008729 hasConceptScore W2034008729C98274493 @default.
• W2034008729 hasIssue "5" @default.
• W2034008729 hasLocation W20340087291 @default.
• W2034008729 hasLocation W20340087292 @default.
• W2034008729 hasOpenAccess W2034008729 @default.
• W2034008729 hasPrimaryLocation W20340087291 @default.
• W2034008729 hasRelatedWork W1998213340 @default.
• W2034008729 hasRelatedWork W2008610508 @default.
• W2034008729 hasRelatedWork W2351830309 @default.
• W2034008729 hasRelatedWork W2363093019 @default.
• W2034008729 hasRelatedWork W2364542266 @default.
• W2034008729 hasRelatedWork W2372787074 @default.
• W2034008729 hasRelatedWork W2373252052 @default.
• W2034008729 hasRelatedWork W2376335381 @default.
• W2034008729 hasRelatedWork W2604757141 @default.
• W2034008729 hasRelatedWork W2777540367 @default.
• W2034008729 hasVolume "31" @default.
• W2034008729 isParatext "false" @default.
• W2034008729 isRetracted "false" @default.
• W2034008729 magId "2034008729" @default.
• W2034008729 workType "article" @default.