FRINK Linked Data Fragments server

Matches in SemOpenAlex for { <https://semopenalex.org/work/W2093205183> ?p ?o ?g. }

• W2093205183 endingPage "1602" @default.
• W2093205183 startingPage "1595" @default.
• W2093205183 abstract "Imatinib mesylate is used to treat chronic myeloid leukemia and advanced gastrointestinal stromal tumors.The purpose of this study was to compare the pharmacokinetics of 2 different strengths of the imatinib formulation containing 100 mg (reference) and 400 mg (test) to satisfy the regulatory requirement for marketing.A single-center, randomized, single-dose, open-label, 2-period, 2-sequence, comparative crossover study with a 14-day washout period was conducted in 30 healthy male volunteers. Plasma samples for the drug analysis were collected up to 72 hours after drug treatment. Participants received either the reference (4 tablets of 100-mg imatinib) or the test (1 tablet of 400-mg imatinib) formulation during the first period and the alternative formulation during the second period. The safety profiles and tolerability of the 2 formulations were also assessed based on physical examinations, laboratory tests, a 12-lead ECG, and vital signs.Thirty participants were initially enrolled; their mean (SD) age, height, weight, and body mass index were 24.9 (2.0) years (range, 23-30 years), 174 (5) cm (range, 164-185 cm), 69.9 (2.0) kg (range, 54.1-87.4 kg), and 23.0 (2.0) kg/m(2) (range, 18.5-26.9 kg/m(2)); 28 healthy participants completed both treatment periods. Two subjects did not complete the study because they withdrew consent for personal reasons. The observed mean (SD) Cmax, AUC0-last, and AUC0-∞ values for the reference formulation were 1792 (357) ng/mL, 28,485 (6274) ng · h/mL, and 29,079 (6371) ng · h/mL, respectively. Corresponding values for the test formulation were 1710 (312) ng/mL, 27,222 (4624) ng · h/mL , and 27,872 (4751) ng · h/mL. The geometric mean ratios (90% CIs) between the 2 formulations at the 400-mg dose of imatinib were 0.9579 (0.9054-1.0136) for Cmax, 0.9652 (0.9174-1.0155) for AUC0-last, and 0.9679 (0.9203-1.0179) for AUC0-∞, respectively. During the study period, 6 adverse events (3 for the reference and 3 for the test formulation) were reported; all were transient, mild, and resolved completely during the treatment period. There were 4 cases of nausea and 1 case each of dizziness and oropharyngeal pain. Four adverse events were considered related to the study drugs.The results showed that despite the different strengths of the 2 imatinib formations, the test and reference formulations both met the regulatory criteria for pharmacokinetic equivalence at a dose of imatinib 400 mg in these healthy Korean male subjects. Both imatinib formulations seemed to be generally well tolerated. ClinicalTrials.gov identifier: NCT01270984." @default.
• W2093205183 created "2016-06-24" @default.
• W2093205183 creator A5015481616 @default.
• W2093205183 creator A5045655039 @default.
• W2093205183 creator A5050866517 @default.
• W2093205183 creator A5081717979 @default.
• W2093205183 date "2013-10-01" @default.
• W2093205183 modified "2023-09-23" @default.
• W2093205183 title "Single-Dose, Randomized Crossover Comparisons of Different-Strength Imatinib Mesylate Formulations in Healthy Korean Male Subjects" @default.
• W2093205183 cites W1978821257 @default.
• W2093205183 cites W2003596377 @default.
• W2093205183 cites W2014933948 @default.
• W2093205183 cites W2021913096 @default.
• W2093205183 cites W2024546486 @default.
• W2093205183 cites W2028959752 @default.
• W2093205183 cites W2034074778 @default.
• W2093205183 cites W2043858938 @default.
• W2093205183 cites W2052667147 @default.
• W2093205183 cites W2124524221 @default.
• W2093205183 cites W2126428160 @default.
• W2093205183 cites W2129433856 @default.
• W2093205183 cites W2135939926 @default.
• W2093205183 cites W2139651041 @default.
• W2093205183 cites W2153484612 @default.
• W2093205183 cites W2162340188 @default.
• W2093205183 cites W2164693883 @default.
• W2093205183 cites W2168752603 @default.
• W2093205183 cites W2329648702 @default.
• W2093205183 cites W2398729192 @default.
• W2093205183 cites W2992837203 @default.
• W2093205183 doi "https://doi.org/10.1016/j.clinthera.2013.08.008" @default.
• W2093205183 hasPubMedId "https://pubmed.ncbi.nlm.nih.gov/24060561" @default.
• W2093205183 hasPublicationYear "2013" @default.
• W2093205183 type Work @default.
• W2093205183 sameAs 2093205183 @default.
• W2093205183 citedByCount "3" @default.
• W2093205183 countsByYear W20932051832015 @default.
• W2093205183 countsByYear W20932051832017 @default.
• W2093205183 crossrefType "journal-article" @default.
• W2093205183 hasAuthorship W2093205183A5015481616 @default.
• W2093205183 hasAuthorship W2093205183A5045655039 @default.
• W2093205183 hasAuthorship W2093205183A5050866517 @default.
• W2093205183 hasAuthorship W2093205183A5081717979 @default.
• W2093205183 hasConcept C112705442 @default.
• W2093205183 hasConcept C126322002 @default.
• W2093205183 hasConcept C142724271 @default.
• W2093205183 hasConcept C197934379 @default.
• W2093205183 hasConcept C204787440 @default.
• W2093205183 hasConcept C22979827 @default.
• W2093205183 hasConcept C27081682 @default.
• W2093205183 hasConcept C2776768635 @default.
• W2093205183 hasConcept C2777583451 @default.
• W2093205183 hasConcept C2778375690 @default.
• W2093205183 hasConcept C2778729363 @default.
• W2093205183 hasConcept C3019892230 @default.
• W2093205183 hasConcept C6557445 @default.
• W2093205183 hasConcept C71924100 @default.
• W2093205183 hasConcept C86803240 @default.
• W2093205183 hasConcept C87813604 @default.
• W2093205183 hasConcept C90924648 @default.
• W2093205183 hasConceptScore W2093205183C112705442 @default.
• W2093205183 hasConceptScore W2093205183C126322002 @default.
• W2093205183 hasConceptScore W2093205183C142724271 @default.
• W2093205183 hasConceptScore W2093205183C197934379 @default.
• W2093205183 hasConceptScore W2093205183C204787440 @default.
• W2093205183 hasConceptScore W2093205183C22979827 @default.
• W2093205183 hasConceptScore W2093205183C27081682 @default.
• W2093205183 hasConceptScore W2093205183C2776768635 @default.
• W2093205183 hasConceptScore W2093205183C2777583451 @default.
• W2093205183 hasConceptScore W2093205183C2778375690 @default.
• W2093205183 hasConceptScore W2093205183C2778729363 @default.
• W2093205183 hasConceptScore W2093205183C3019892230 @default.
• W2093205183 hasConceptScore W2093205183C6557445 @default.
• W2093205183 hasConceptScore W2093205183C71924100 @default.
• W2093205183 hasConceptScore W2093205183C86803240 @default.
• W2093205183 hasConceptScore W2093205183C87813604 @default.
• W2093205183 hasConceptScore W2093205183C90924648 @default.
• W2093205183 hasIssue "10" @default.
• W2093205183 hasLocation W20932051831 @default.
• W2093205183 hasLocation W20932051832 @default.
• W2093205183 hasOpenAccess W2093205183 @default.
• W2093205183 hasPrimaryLocation W20932051831 @default.
• W2093205183 hasRelatedWork W2074207917 @default.
• W2093205183 hasRelatedWork W2085287792 @default.
• W2093205183 hasRelatedWork W2144299645 @default.
• W2093205183 hasRelatedWork W2351830309 @default.
• W2093205183 hasRelatedWork W2353965361 @default.
• W2093205183 hasRelatedWork W2363093019 @default.
• W2093205183 hasRelatedWork W2372787074 @default.
• W2093205183 hasRelatedWork W2376335381 @default.
• W2093205183 hasRelatedWork W2604757141 @default.
• W2093205183 hasRelatedWork W3146022116 @default.
• W2093205183 hasVolume "35" @default.
• W2093205183 isParatext "false" @default.
• W2093205183 isRetracted "false" @default.
• W2093205183 magId "2093205183" @default.
• W2093205183 workType "article" @default.