{"id":"https://openalex.org/W1992339833","doi":"https://doi.org/10.1097/mjt.0b013e318205427a","title":"Pharmacokinetic Studies in Women of 2 Novel Oral Formulations of Tranexamic Acid Therapy for Heavy Menstrual Bleeding","display_name":"Pharmacokinetic Studies in Women of 2 Novel Oral Formulations of Tranexamic Acid Therapy for Heavy Menstrual Bleeding","publication_year":2011,"publication_date":"2011-01-20","ids":{"openalex":"https://openalex.org/W1992339833","doi":"https://doi.org/10.1097/mjt.0b013e318205427a","mag":"1992339833","pmid":"https://pubmed.ncbi.nlm.nih.gov/21248612"},"language":"en","primary_location":{"id":"doi:10.1097/mjt.0b013e318205427a","doi":"https://doi.org/10.1097/mjt.0b013e318205427a","is_oa":false,"landing_page_url":"https://doi.org/10.1097/mjt.0b013e318205427a","pdf_url":null,"source":{"id":"https://openalex.org/S67118044","display_name":"American Journal of Therapeutics","issn_l":"1075-2765","issn":["1075-2765","1536-3686"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["cwts-core","dongbi-c","doyens","jufo-1","ki-jl-1","medline","norway-1","poland-40","russia-white-list-2"],"host_organization":"https://openalex.org/P4310315671","host_organization_name":"Lippincott Williams & Wilkins","host_organization_lineage":["https://openalex.org/P4310315671","https://openalex.org/P4310318547"],"host_organization_lineage_names":["Lippincott Williams & Wilkins","Wolters Kluwer"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"American Journal of Therapeutics","raw_type":"journal-article"},"volume":null,"type":"article","is_traditional":true,"indexed_in":["crossref","pubmed"],"open_access":{"is_oa":false,"oa_status":"closed","oa_url":null,"any_repository_has_fulltext":false},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5012496878","display_name":"Keith A. Moore","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":true,"raw_author_name":"Keith A. Moore","raw_affiliation_strings":["Clinical Research and Development, Xanodyne Pharmaceuticals, Inc., Newport, KY 41071-4563, USA. kmoore@xanodyne.com","Clinical Research and Development, Xanodyne Pharmaceuticals, Inc., Newport, KY"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Clinical Research and Development, Xanodyne Pharmaceuticals, Inc., Newport, KY 41071-4563, USA. kmoore@xanodyne.com","institution_ids":[]},{"raw_affiliation_string":"Clinical Research and Development, Xanodyne Pharmaceuticals, Inc., Newport, KY","institution_ids":[]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5114119329","display_name":"Isabelle Morin","orcid":"https://orcid.org/0009-0007-9346-7708","observed_orcids":["https://orcid.org/0009-0007-9346-7708"]},"institutions":[{"id":"https://openalex.org/I4210145368","display_name":"Celerion (Canada)","ror":"https://ror.org/0491h6661","country_code":"CA","type":"company","lineage":["https://openalex.org/I4210103107","https://openalex.org/I4210145368"]}],"countries":["CA"],"is_corresponding":false,"raw_author_name":"Isabelle Morin","raw_affiliation_strings":["Clinical Pharmacology, Celerion (formerly MDS Pharma Services), Saint-Laurent, Qu\u00e9bec, Canada"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Clinical Pharmacology, Celerion (formerly MDS Pharma Services), Saint-Laurent, Qu\u00e9bec, Canada","institution_ids":["https://openalex.org/I4210145368"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5087660192","display_name":"Ted Marenco","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I4210145368","display_name":"Celerion (Canada)","ror":"https://ror.org/0491h6661","country_code":"CA","type":"company","lineage":["https://openalex.org/I4210103107","https://openalex.org/I4210145368"]}],"countries":["CA"],"is_corresponding":false,"raw_author_name":"Ted Marenco","raw_affiliation_strings":["Clinical Pharmacology, Celerion (formerly MDS Pharma Services), Saint-Laurent, Qu\u00e9bec, Canada"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Clinical Pharmacology, Celerion (formerly MDS Pharma Services), Saint-Laurent, Qu\u00e9bec, Canada","institution_ids":["https://openalex.org/I4210145368"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5066487380","display_name":"Jean R. Lavigne","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I4210145368","display_name":"Celerion (Canada)","ror":"https://ror.org/0491h6661","country_code":"CA","type":"company","lineage":["https://openalex.org/I4210103107","https://openalex.org/I4210145368"]}],"countries":["CA"],"is_corresponding":false,"raw_author_name":"Jean R. Lavigne","raw_affiliation_strings":["Clinical Pharmacology, Celerion (formerly MDS Pharma Services), Saint-Laurent, Qu\u00e9bec, Canada"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Clinical Pharmacology, Celerion (formerly MDS Pharma Services), Saint-Laurent, Qu\u00e9bec, Canada","institution_ids":["https://openalex.org/I4210145368"]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5103527855","display_name":"Gaetano Morelli","orcid":"https://orcid.org/0009-0005-8238-8751","observed_orcids":["https://orcid.org/0009-0005-8238-8751"]},"institutions":[{"id":"https://openalex.org/I4210145368","display_name":"Celerion (Canada)","ror":"https://ror.org/0491h6661","country_code":"CA","type":"company","lineage":["https://openalex.org/I4210103107","https://openalex.org/I4210145368"]}],"countries":["CA"],"is_corresponding":false,"raw_author_name":"Gaetano Morelli","raw_affiliation_strings":["Clinical Pharmacology, Celerion (formerly MDS Pharma Services), Saint-Laurent, Qu\u00e9bec, Canada"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Clinical Pharmacology, Celerion (formerly MDS Pharma Services), Saint-Laurent, Qu\u00e9bec, Canada","institution_ids":["https://openalex.org/I4210145368"]}]}],"institutions":[],"countries_distinct_count":1,"institutions_distinct_count":1,"corresponding_author_ids":["https://openalex.org/A5012496878"],"corresponding_institution_ids":[],"apc_list":null,"apc_paid":null,"fwci":2.0853,"has_fulltext":false,"cited_by_count":16,"citation_normalized_percentile":{"value":0.874324,"is_in_top_1_percent":false,"is_in_top_10_percent":false},"cited_by_percentile_year":{"min":87,"max":98},"biblio":{"volume":"19","issue":"3","first_page":"190","last_page":"198"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T10693","display_name":"Blood transfusion and management","score":0.6054999828338623,"subfield":{"id":"https://openalex.org/subfields/2720","display_name":"Hematology"},"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/T10693","display_name":"Blood transfusion and management","score":0.6054999828338623,"subfield":{"id":"https://openalex.org/subfields/2720","display_name":"Hematology"},"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/T12547","display_name":"Pharmaceutical studies and practices","score":0.121799997985363,"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"}},{"id":"https://openalex.org/T12054","display_name":"Menstrual Health and Disorders","score":0.07639999687671661,"subfield":{"id":"https://openalex.org/subfields/2739","display_name":"Public Health, Environmental and Occupational 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/tranexamic-acid","display_name":"tranexamic acid","score":1.0},{"id":"https://openalex.org/keywords/menorrhagia","display_name":"menorrhagia","score":0.925000011920929},{"id":"https://openalex.org/keywords/pharmacokinetics","display_name":"pharmacokinetics","score":0.9649999737739563},{"id":"https://openalex.org/keywords/modified-release-tablets","display_name":"modified release tablets","score":0.8610000014305115},{"id":"https://openalex.org/keywords/immediate-release-formulation","display_name":"immediate-release formulation","score":0.9279999732971191},{"id":"https://openalex.org/keywords/delayed-release-formulation","display_name":"delayed-release formulation","score":0.9929999709129333},{"id":"https://openalex.org/keywords/food-effects-on-drug-absorption","display_name":"food effect on absorption","score":0.6460000276565552},{"id":"https://openalex.org/keywords/high-fat-meal","display_name":"high-fat meal","score":0.9319999814033508},{"id":"https://openalex.org/keywords/steady-state-dosing","display_name":"steady-state dosing","score":0.7639999985694885},{"id":"https://openalex.org/keywords/plasma-drug-concentration","display_name":"plasma drug concentration","score":0.5619999766349792},{"id":"https://openalex.org/keywords/women","display_name":"women","score":0.36399999260902405}],"concepts":[{"id":"https://openalex.org/C2779637338","wikidata":"https://www.wikidata.org/wiki/Q418666","display_name":"Tranexamic acid","level":3,"score":0.9970705509185791},{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.8722726106643677},{"id":"https://openalex.org/C112705442","wikidata":"https://www.wikidata.org/wiki/Q323936","display_name":"Pharmacokinetics","level":2,"score":0.704086422920227},{"id":"https://openalex.org/C2781413609","wikidata":"https://www.wikidata.org/wiki/Q7308373","display_name":"Regimen","level":2,"score":0.5671421885490417},{"id":"https://openalex.org/C42219234","wikidata":"https://www.wikidata.org/wiki/Q131130","display_name":"Anesthesia","level":1,"score":0.4247034788131714},{"id":"https://openalex.org/C98274493","wikidata":"https://www.wikidata.org/wiki/Q128406","display_name":"Pharmacology","level":1,"score":0.3703748285770416},{"id":"https://openalex.org/C141071460","wikidata":"https://www.wikidata.org/wiki/Q40821","display_name":"Surgery","level":1,"score":0.23453658819198608},{"id":"https://openalex.org/C2991743468","wikidata":"https://www.wikidata.org/wiki/Q166019","display_name":"Blood loss","level":2,"score":0.11399629712104797}],"mesh":[{"descriptor_ui":"D000284","descriptor_name":"Administration, Oral","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D000293","descriptor_name":"Adolescent","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D000328","descriptor_name":"Adult","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D000933","descriptor_name":"Antifibrinolytic Agents","qualifier_ui":"Q000008","qualifier_name":"administration & dosage","is_major_topic":false},{"descriptor_ui":"D000933","descriptor_name":"Antifibrinolytic Agents","qualifier_ui":"Q000009","qualifier_name":"adverse effects","is_major_topic":false},{"descriptor_ui":"D000933","descriptor_name":"Antifibrinolytic Agents","qualifier_ui":"Q000627","qualifier_name":"therapeutic use","is_major_topic":true},{"descriptor_ui":"D003692","descriptor_name":"Delayed-Action Preparations","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D005215","descriptor_name":"Fasting","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D005260","descriptor_name":"Female","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D006801","descriptor_name":"Humans","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D008595","descriptor_name":"Menorrhagia","qualifier_ui":"Q000188","qualifier_name":"drug therapy","is_major_topic":true},{"descriptor_ui":"D008875","descriptor_name":"Middle Aged","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D013607","descriptor_name":"Tablets","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D013997","descriptor_name":"Time Factors","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D014148","descriptor_name":"Tranexamic Acid","qualifier_ui":"Q000008","qualifier_name":"administration & dosage","is_major_topic":false},{"descriptor_ui":"D014148","descriptor_name":"Tranexamic Acid","qualifier_ui":"Q000009","qualifier_name":"adverse effects","is_major_topic":false},{"descriptor_ui":"D014148","descriptor_name":"Tranexamic Acid","qualifier_ui":"Q000627","qualifier_name":"therapeutic use","is_major_topic":false},{"descriptor_ui":"D016896","descriptor_name":"Treatment Outcome","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D018565","descriptor_name":"Food-Drug Interactions","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D055815","descriptor_name":"Young Adult","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D059305","descriptor_name":"Diet, High-Fat","qualifier_ui":null,"qualifier_name":null,"is_major_topic":true}],"locations_count":2,"locations":[{"id":"doi:10.1097/mjt.0b013e318205427a","doi":"https://doi.org/10.1097/mjt.0b013e318205427a","is_oa":false,"landing_page_url":"https://doi.org/10.1097/mjt.0b013e318205427a","pdf_url":null,"source":{"id":"https://openalex.org/S67118044","display_name":"American Journal of Therapeutics","issn_l":"1075-2765","issn":["1075-2765","1536-3686"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["cwts-core","dongbi-c","doyens","jufo-1","ki-jl-1","medline","norway-1","poland-40","russia-white-list-2"],"host_organization":"https://openalex.org/P4310315671","host_organization_name":"Lippincott Williams & Wilkins","host_organization_lineage":["https://openalex.org/P4310315671","https://openalex.org/P4310318547"],"host_organization_lineage_names":["Lippincott Williams & Wilkins","Wolters Kluwer"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"American Journal of Therapeutics","raw_type":"journal-article"},{"id":"pmid:21248612","doi":null,"is_oa":false,"landing_page_url":"https://pubmed.ncbi.nlm.nih.gov/21248612","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":"American journal of therapeutics","raw_type":"Comparative Study"}],"best_oa_location":null,"sustainable_development_goals":[{"display_name":"Good health and well-being","score":0.9922999739646912,"id":"https://metadata.un.org/sdg/3"}],"study_designs":[{"display_name":"Clinical Trial","id":"https://openalex.org/study-designs/clinical-trial"}],"awards":[],"funders":[],"has_content":{"pdf":false,"grobid_xml":false},"content_urls":null,"referenced_works_count":15,"referenced_works":["https://openalex.org/W202129753","https://openalex.org/W1993653149","https://openalex.org/W1995103763","https://openalex.org/W1999546242","https://openalex.org/W2001022087","https://openalex.org/W2018289814","https://openalex.org/W2021738675","https://openalex.org/W2032960682","https://openalex.org/W2036468563","https://openalex.org/W2076652047","https://openalex.org/W2091692603","https://openalex.org/W2095465279","https://openalex.org/W2103865819","https://openalex.org/W2107648329","https://openalex.org/W2120216515"],"related_works":["https://openalex.org/W2146711058","https://openalex.org/W1966541007","https://openalex.org/W2103413146","https://openalex.org/W4205426687","https://openalex.org/W2321973160","https://openalex.org/W3011839023","https://openalex.org/W1982967451","https://openalex.org/W4242216037","https://openalex.org/W2414534027","https://openalex.org/W2398617020"],"abstract_inverted_index":{"Two":[0],"randomized,":[1],"open-label":[2],"clinical":[3,57,243],"studies":[4,45],"involving":[5],"healthy":[6],"female":[7],"volunteers":[8],"aged":[9],"18-45":[10],"years":[11],"(study":[12],"1,":[13,65],"N":[14,19],"=":[15,20],"32;":[16],"study":[17,64,95],"2,":[18,96],"40)":[21],"are":[22],"described,":[23],"which":[24],"characterize":[25],"the":[26,49,169,188,200,219],"pharmacokinetics":[27],"and":[28,79,138,148,180,209],"steady-state":[29,216],"dosage":[30,114],"regimen":[31,115],"performance":[32,217],"of":[33,43,74,116,182,199,218],"2":[34],"novel,":[35],"modified-release":[36],"tranexamic":[37,75,80,99,103,126,145,149,159,174,184,220],"acid":[38,76,81,100,104,127,146,150,160,175,185,221],"tablet":[39],"formulations.":[40],"The":[41,207],"objective":[42],"these":[44],"was":[46],"to":[47,53,235,241],"identify":[48],"optimum":[50],"product":[51,224],"formulation":[52,202],"advance":[54],"into":[55],"late-phase":[56,242],"trials":[58,244],"for":[59,122,233],"heavy":[60,248],"menstrual":[61,249],"bleeding.":[62,250],"For":[63,94],"participants":[66,97],"received":[67,98],"single":[68,108],"1.3-g":[69,109,144,223],"doses":[70],"(2":[71],"650-mg":[72],"tablets)":[73],"modified-immediate-release":[77],"(MIR)":[78],"delayed-release":[82],"(DR)":[83],"formulations":[84,211],"under":[85],"fasting":[86],"conditions":[87,91],"compared":[88],"with":[89,173,196,247],"nonfasting":[90],"(after":[92],"breakfast).":[93],"MIR":[101,147,161,201,208,222],"or":[102,229],"DR":[105,151,210],"as":[106],"a":[107,113,143,164],"dose":[110],"followed":[111],"by":[112],"1.3":[117,197],"g":[118,198],"every":[119,204,226],"8":[120,205,227],"hours":[121,137,141],"5":[123,236],"days.":[124],"Plasma":[125],"concentrations":[128,186],"reached":[129],"minimum":[130],"effective":[131],"levels":[132],"(\u22655":[133],"\u03bcg/mL)":[134,192],"within":[135,139,187],"1.5":[136],"3":[140,230],"after":[142],"dose,":[152],"respectively.":[153],"Food":[154],"did":[155],"not":[156],"appreciably":[157],"influence":[158],"pharmacokinetics,":[162],"whereas":[163],"high-fat":[165],"meal":[166],"significantly":[167],"lowered":[168],"maximum":[170],"concentration":[171],"produced":[172],"DR.":[176],"Peak":[177],"systemic":[178],"exposure":[179],"maintenance":[181],"plasma":[183],"therapeutic":[189],"range":[190],"(5-15":[191],"were":[193,212],"optimally":[194],"achieved":[195],"dosed":[203],"hours.":[206],"well":[213],"tolerated.":[214],"Peak-to-trough":[215],"(dosed":[225],"hours,":[228],"times":[231],"daily,":[232],"up":[234],"days)":[237],"supported":[238],"its":[239],"advancement":[240],"in":[245],"women":[246]},"counts_by_year":[{"year":2021,"cited_by_count":1},{"year":2020,"cited_by_count":2},{"year":2019,"cited_by_count":2},{"year":2016,"cited_by_count":1},{"year":2013,"cited_by_count":2},{"year":2012,"cited_by_count":5}],"updated_date":"2026-11-04T10:54:05.112534","created_date":"2016-06-24T00:00:00"}