{"id":"https://openalex.org/W2097375302","doi":null,"title":"Bioequivalence Comparison of Two Formulations of Fixed-Dose Combination Glimepiride/Metformin (2/500 mg)Tablets in Healthy Volunteers.","display_name":"Bioequivalence Comparison of Two Formulations of Fixed-Dose Combination Glimepiride/Metformin (2/500 mg)Tablets in Healthy Volunteers.","publication_year":2014,"publication_date":"2014-01-01","ids":{"openalex":"https://openalex.org/W2097375302","mag":"2097375302","pmid":"https://pubmed.ncbi.nlm.nih.gov/25237332","pmcid":"https://www.ncbi.nlm.nih.gov/pmc/articles/4157012"},"language":"en","primary_location":{"id":"pmh:oai:pubmedcentral.nih.gov:4157012","doi":null,"is_oa":true,"landing_page_url":"https://www.ncbi.nlm.nih.gov/pmc/articles/4157012","pdf_url":null,"source":{"id":"https://openalex.org/S2764455111","display_name":"PubMed Central","issn_l":null,"issn":null,"is_oa":true,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I1299303238","host_organization_name":"National Institutes of Health","host_organization_lineage":["https://openalex.org/I1299303238"],"host_organization_lineage_names":[],"type":"repository"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Iran J Pharm Res","raw_type":"Text"},"volume":null,"type":"article","is_traditional":true,"indexed_in":["pubmed"],"open_access":{"is_oa":true,"oa_status":"green","oa_url":"https://www.ncbi.nlm.nih.gov/pmc/articles/4157012","any_repository_has_fulltext":true},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5100820924","display_name":"Sang-Hoon Jung","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I196345858","display_name":"Chungnam National University","ror":"https://ror.org/0227as991","country_code":"KR","type":"education","lineage":["https://openalex.org/I196345858"]}],"countries":["KR"],"is_corresponding":false,"raw_author_name":"Sang-Hoon Jung","raw_affiliation_strings":["College of Pharmacy, Chungnam National University, Korea. ; Medical Department, Novo Nordisk, Pharma Korea, Korea"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"College of Pharmacy, Chungnam National University, Korea. ; Medical Department, Novo Nordisk, Pharma Korea, Korea","institution_ids":["https://openalex.org/I196345858"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5022293663","display_name":"Jung\u2010woo Chae","orcid":"https://orcid.org/0000-0001-6026-7063","observed_orcids":["https://orcid.org/0000-0001-6026-7063"]},"institutions":[{"id":"https://openalex.org/I196345858","display_name":"Chungnam National University","ror":"https://ror.org/0227as991","country_code":"KR","type":"education","lineage":["https://openalex.org/I196345858"]}],"countries":["KR"],"is_corresponding":false,"raw_author_name":"Jung-Woo Chae","raw_affiliation_strings":["College of Pharmacy, Chungnam National University, Korea"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"College of Pharmacy, Chungnam National University, Korea","institution_ids":["https://openalex.org/I196345858"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5102109820","display_name":"Byungjeong Song","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I196345858","display_name":"Chungnam National University","ror":"https://ror.org/0227as991","country_code":"KR","type":"education","lineage":["https://openalex.org/I196345858"]}],"countries":["KR"],"is_corresponding":false,"raw_author_name":"Byung-Jeong Song","raw_affiliation_strings":["College of Pharmacy, Chungnam National University, Korea"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"College of Pharmacy, Chungnam National University, Korea","institution_ids":["https://openalex.org/I196345858"]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5017003997","display_name":"Kwang-Il Kwona","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I196345858","display_name":"Chungnam National University","ror":"https://ror.org/0227as991","country_code":"KR","type":"education","lineage":["https://openalex.org/I196345858"]}],"countries":["KR"],"is_corresponding":false,"raw_author_name":"Kwang-Il Kwona","raw_affiliation_strings":["College of Pharmacy, Chungnam National University, Korea"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"College of Pharmacy, Chungnam National University, Korea","institution_ids":["https://openalex.org/I196345858"]}]}],"institutions":[],"countries_distinct_count":1,"institutions_distinct_count":1,"corresponding_author_ids":[],"corresponding_institution_ids":["https://openalex.org/I196345858"],"apc_list":null,"apc_paid":null,"fwci":0.654,"has_fulltext":false,"cited_by_count":5,"citation_normalized_percentile":{"value":0.71027159,"is_in_top_1_percent":false,"is_in_top_10_percent":false},"cited_by_percentile_year":{"min":88,"max":93},"biblio":{"volume":"13","issue":"2","first_page":"365","last_page":"71"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T10401","display_name":"Diabetes Treatment and Management","score":0.8330000042915344,"subfield":{"id":"https://openalex.org/subfields/2712","display_name":"Endocrinology, Diabetes and Metabolism"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},"topics":[{"id":"https://openalex.org/T10401","display_name":"Diabetes Treatment and Management","score":0.8330000042915344,"subfield":{"id":"https://openalex.org/subfields/2712","display_name":"Endocrinology, Diabetes and Metabolism"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},{"id":"https://openalex.org/T11235","display_name":"Statistical Methods in Clinical Trials","score":0.034699998795986176,"subfield":{"id":"https://openalex.org/subfields/2613","display_name":"Statistics and Probability"},"field":{"id":"https://openalex.org/fields/26","display_name":"Mathematics"},"domain":{"id":"https://openalex.org/domains/3","display_name":"Physical Sciences"}},{"id":"https://openalex.org/T12547","display_name":"Pharmaceutical studies and practices","score":0.021900000050663948,"subfield":{"id":"https://openalex.org/subfields/2735","display_name":"Pediatrics, Perinatology and Child Health"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/glimepiride","display_name":"glimepiride","score":0.9589999914169312},{"id":"https://openalex.org/keywords/metformin","display_name":"metformin","score":1.0},{"id":"https://openalex.org/keywords/fixed-dose-combination","display_name":"fixed-dose combination","score":0.8560000061988831},{"id":"https://openalex.org/keywords/bioequivalence","display_name":"bioequivalence","score":0.8960000276565552},{"id":"https://openalex.org/keywords/generic-formulations","display_name":"generic formulations","score":0.777999997138977},{"id":"https://openalex.org/keywords/pharmacokinetics","display_name":"pharmacokinetics","score":0.7770000100135803},{"id":"https://openalex.org/keywords/type-2-diabetes","display_name":"type 2 diabetes","score":0.8989999890327454},{"id":"https://openalex.org/keywords/antidiabetic-drugs","display_name":"antidiabetic drugs","score":0.8870000243186951},{"id":"https://openalex.org/keywords/tablet-formulation","display_name":"tablet formulation","score":0.4569999873638153},{"id":"https://openalex.org/keywords/healthy-volunteers","display_name":"healthy volunteers","score":0.7630000114440918},{"id":"https://openalex.org/keywords/cmax","display_name":"Cmax","score":0.6050000190734863},{"id":"https://openalex.org/keywords/tolerability","display_name":"tolerability","score":0.6700000166893005},{"id":"https://openalex.org/keywords/adverse-events","display_name":"adverse events","score":0.4860000014305115},{"id":"https://openalex.org/keywords/drug-interactions","display_name":"drug interactions","score":0.32600000500679016},{"id":"https://openalex.org/keywords/food-effect","display_name":"food effect","score":0.3330000042915344},{"id":"https://openalex.org/keywords/renal-dysfunction","display_name":"renal dysfunction","score":0.3449999988079071},{"id":"https://openalex.org/keywords/liver-dysfunction","display_name":"liver dysfunction","score":0.7139999866485596},{"id":"https://openalex.org/keywords/liver-function","display_name":"liver function","score":0.6209999918937683}],"concepts":[{"id":"https://openalex.org/C42404028","wikidata":"https://www.wikidata.org/wiki/Q864940","display_name":"Bioequivalence","level":3,"score":0.9364405870437622},{"id":"https://openalex.org/C2776307423","wikidata":"https://www.wikidata.org/wiki/Q425027","display_name":"Glimepiride","level":4,"score":0.907058835029602},{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.809934139251709},{"id":"https://openalex.org/C112705442","wikidata":"https://www.wikidata.org/wiki/Q323936","display_name":"Pharmacokinetics","level":2,"score":0.7047953009605408},{"id":"https://openalex.org/C2780323712","wikidata":"https://www.wikidata.org/wiki/Q19484","display_name":"Metformin","level":3,"score":0.6850986480712891},{"id":"https://openalex.org/C2778375690","wikidata":"https://www.wikidata.org/wiki/Q7814214","display_name":"Tolerability","level":3,"score":0.6738669276237488},{"id":"https://openalex.org/C181389837","wikidata":"https://www.wikidata.org/wiki/Q461809","display_name":"Bioavailability","level":2,"score":0.6574155688285828},{"id":"https://openalex.org/C87813604","wikidata":"https://www.wikidata.org/wiki/Q1242899","display_name":"Crossover study","level":4,"score":0.621642529964447},{"id":"https://openalex.org/C2776623344","wikidata":"https://www.wikidata.org/wiki/Q5456317","display_name":"Fixed-dose combination","level":2,"score":0.4896717369556427},{"id":"https://openalex.org/C98274493","wikidata":"https://www.wikidata.org/wiki/Q128406","display_name":"Pharmacology","level":1,"score":0.48215267062187195},{"id":"https://openalex.org/C2777180221","wikidata":"https://www.wikidata.org/wiki/Q3025883","display_name":"Type 2 diabetes","level":3,"score":0.41328519582748413},{"id":"https://openalex.org/C126322002","wikidata":"https://www.wikidata.org/wiki/Q11180","display_name":"Internal medicine","level":1,"score":0.25690317153930664},{"id":"https://openalex.org/C197934379","wikidata":"https://www.wikidata.org/wiki/Q2047938","display_name":"Adverse effect","level":2,"score":0.23276901245117188},{"id":"https://openalex.org/C555293320","wikidata":"https://www.wikidata.org/wiki/Q12206","display_name":"Diabetes mellitus","level":2,"score":0.2064918577671051},{"id":"https://openalex.org/C2779306644","wikidata":"https://www.wikidata.org/wiki/Q2002370","display_name":"Insulin","level":2,"score":0.12002316117286682},{"id":"https://openalex.org/C134018914","wikidata":"https://www.wikidata.org/wiki/Q162606","display_name":"Endocrinology","level":1,"score":0.11343526840209961},{"id":"https://openalex.org/C27081682","wikidata":"https://www.wikidata.org/wiki/Q269829","display_name":"Placebo","level":3,"score":0.058119893074035645},{"id":"https://openalex.org/C142724271","wikidata":"https://www.wikidata.org/wiki/Q7208","display_name":"Pathology","level":1,"score":0.0},{"id":"https://openalex.org/C204787440","wikidata":"https://www.wikidata.org/wiki/Q188504","display_name":"Alternative medicine","level":2,"score":0.0}],"mesh":[],"locations_count":3,"locations":[{"id":"pmh:oai:pubmedcentral.nih.gov:4157012","doi":null,"is_oa":true,"landing_page_url":"https://www.ncbi.nlm.nih.gov/pmc/articles/4157012","pdf_url":null,"source":{"id":"https://openalex.org/S2764455111","display_name":"PubMed Central","issn_l":null,"issn":null,"is_oa":true,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I1299303238","host_organization_name":"National Institutes of Health","host_organization_lineage":["https://openalex.org/I1299303238"],"host_organization_lineage_names":[],"type":"repository"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Iran J Pharm Res","raw_type":"Text"},{"id":"pmid:25237332","doi":null,"is_oa":false,"landing_page_url":"https://pubmed.ncbi.nlm.nih.gov/25237332","pdf_url":null,"source":{"id":"https://openalex.org/S4306525036","display_name":"PubMed","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I1299303238","host_organization_name":"National Institutes of Health","host_organization_lineage":["https://openalex.org/I1299303238"],"host_organization_lineage_names":[],"type":"repository"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Iranian journal of pharmaceutical research : IJPR","raw_type":"Journal Article"},{"id":"mag:2097375302","doi":null,"is_oa":false,"landing_page_url":"https://pubmed.ncbi.nlm.nih.gov/25237332","pdf_url":null,"source":{"id":"https://openalex.org/S4306525036","display_name":"PubMed","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I1299303238","host_organization_name":"National Institutes of Health","host_organization_lineage":["https://openalex.org/I1299303238"],"host_organization_lineage_names":[],"type":"repository"},"license":null,"license_id":null,"version":null,"is_accepted":false,"is_published":false,"raw_source_name":"PubMed","raw_type":null}],"best_oa_location":{"id":"pmh:oai:pubmedcentral.nih.gov:4157012","doi":null,"is_oa":true,"landing_page_url":"https://www.ncbi.nlm.nih.gov/pmc/articles/4157012","pdf_url":null,"source":{"id":"https://openalex.org/S2764455111","display_name":"PubMed Central","issn_l":null,"issn":null,"is_oa":true,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I1299303238","host_organization_name":"National Institutes of Health","host_organization_lineage":["https://openalex.org/I1299303238"],"host_organization_lineage_names":[],"type":"repository"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Iran J Pharm Res","raw_type":"Text"},"sustainable_development_goals":[{"id":"https://metadata.un.org/sdg/3","display_name":"Good health and well-being","score":0.9922999739646912}],"study_designs":[{"id":"https://openalex.org/study-designs/clinical-trial","display_name":"Clinical Trial"}],"awards":[],"funders":[],"has_content":{"grobid_xml":false,"pdf":false},"content_urls":null,"referenced_works_count":31,"referenced_works":["https://openalex.org/W255240257","https://openalex.org/W1515666340","https://openalex.org/W1547447684","https://openalex.org/W1554041676","https://openalex.org/W1973748734","https://openalex.org/W1994470496","https://openalex.org/W1994512273","https://openalex.org/W1995404454","https://openalex.org/W2002779028","https://openalex.org/W2004014076","https://openalex.org/W2007850344","https://openalex.org/W2014816693","https://openalex.org/W2025501687","https://openalex.org/W2043316108","https://openalex.org/W2046523997","https://openalex.org/W2052425627","https://openalex.org/W2069150029","https://openalex.org/W2071835038","https://openalex.org/W2079229392","https://openalex.org/W2088831132","https://openalex.org/W2091239935","https://openalex.org/W2094625675","https://openalex.org/W2108685753","https://openalex.org/W2114041992","https://openalex.org/W2135326009","https://openalex.org/W2146877877","https://openalex.org/W2156810154","https://openalex.org/W2324992560","https://openalex.org/W2412092503","https://openalex.org/W2413432849","https://openalex.org/W2418881601"],"related_works":["https://openalex.org/W2056735898","https://openalex.org/W2088831132","https://openalex.org/W2529097152","https://openalex.org/W2070695965","https://openalex.org/W2124579622","https://openalex.org/W3030728691","https://openalex.org/W7081977906","https://openalex.org/W2797632374","https://openalex.org/W7104057571","https://openalex.org/W4394676126"],"abstract_inverted_index":{"Glimepiride/metformin":[0],"(2/500":[1,18,102,252],"mg)":[2,19,103,253],"is":[3],"an":[4,96],"oral":[5],"antihyperglycemic":[6],"agent":[7],"for":[8,34,177,261],"the":[9,42,45,50,56,100,118,124,165,169,174,183,199,219,231,257],"treatment":[10],"of":[11,44,55,168,173,187,218,250],"type":[12],"2":[13],"diabetes.":[14],"A":[15],"generic":[16],"glimepiride/metformin":[17,101,251],"fixed-dose":[20],"combination":[21],"(FDC)":[22],"tablet":[23,98],"was":[24,29,73,121,161],"developed":[25],"recently.":[26],"This":[27,66],"study":[28,200],"designed":[30],"to":[31,36,40,94],"collect":[32],"data":[33],"submission":[35],"Korean":[37,86,258],"regulatory":[38,185,259],"authorities":[39],"allow":[41],"marketing":[43],"test":[46,57,104,239,248],"formulation.":[47],"We":[48],"evaluated":[49],"comparative":[51],"bioavailability":[52],"and":[53,58,108,123,132,154,179,197,209,222,226,235,240],"tolerability":[54],"reference":[59,106,241],"formulations":[60,176,242],"in":[61,79],"healthy":[62,192],"male":[63,85,193],"adult":[64],"volunteers.":[65],"single-dose,":[67],"randomized,":[68],"double-blind,":[69],"two-way":[70],"crossover":[71],"trial":[72],"conducted":[74],"at":[75,140],"Bestian":[76],"Medical":[77],"Center":[78],"Bucheon,":[80],"Korea.":[81],"In":[82,189],"total,":[83,190],"40":[84,191],"volunteers":[87],"were":[88,92,111,127,134,181,195,224,233],"enrolled.":[89],"The":[90,130,215,238,247],"subjects":[91,194],"randomized":[93],"receive":[95],"FDC":[97,254],"containing":[99],"or":[105],"formulation,":[107],"pharmacokinetic(PK)":[109],"parameters":[110,126],"measured.":[112],"After":[113],"a":[114],"1-week":[115],"washout":[116],"period,":[117],"other":[119],"formulation":[120,249],"administered":[122],"PK":[125,245],"measured":[128],"again.":[129],"Cmax":[131,178,221],"AUCt":[133,180,223],"determined":[135],"from":[136],"blood":[137],"samples":[138],"obtained":[139],"0,":[141],"0.5,":[142],"1,":[143],"1.5,":[144],"2,":[145],"2.5,":[146],"3,":[147],"3.5,":[148],"4,":[149],"5,":[150],"6,":[151],"8,":[152],"12,":[153],"24":[155],"h":[156],"after":[157],"drug":[158],"administration.":[159],"Bioequivalence":[160],"considered":[162],"established":[163],"if":[164],"90%":[166],"CIs":[167],"geometric":[170],"mean":[171],"ratios(GMRs)":[172],"test-to-reference":[175],"within":[182],"predetermined":[184],"range":[186],"80-125%.":[188],"enrolled":[196],"completed":[198],"(mean":[201],"[SD]":[202],"age,":[203],"23.2[2.26]years[range,":[204],"19-30years];weight,":[205],"68.95[8.30]Kg[range,":[206],"52.0-87.0":[207],"Kg];":[208],"height,":[210],"175.4[5.34]":[211],"cm[range,":[212],"164-189":[213],"cm]).":[214],"GMRs(90%":[216],"CI)":[217],"glimepiride":[220],"1.006(0.947-1.069)":[225],"1.010(0.953-1.071),":[227],"respectively.":[228,237],"For":[229],"metformin,":[230],"values":[232],"1.019(0.959-1.083)":[234],"1.035(0.989-1.084),":[236],"had":[243],"similar":[244],"parameters.":[246],"tablets":[255],"met":[256],"criteria":[260],"bioequivalence.":[262]},"counts_by_year":[{"year":2025,"cited_by_count":1},{"year":2019,"cited_by_count":1},{"year":2017,"cited_by_count":1},{"year":2016,"cited_by_count":1},{"year":2015,"cited_by_count":1}],"updated_date":"2026-10-28T10:33:24.094632","created_date":"2016-06-24T00:00:00"}
