{"id":"https://openalex.org/W7225743568","doi":"https://doi.org/10.21203/rs.3.rs-11207478/v1","title":"Pharmacokinetics of ganaplacide and lumefantrine in a pediatric population with Plasmodium falciparum uncomplicated malaria, treated with ganaplacide plus lumefantrine solid dispersion formulation: analysis of data from KALUMI, a multinational Phase 2 study","display_name":"Pharmacokinetics of ganaplacide and lumefantrine in a pediatric population with Plasmodium falciparum uncomplicated malaria, treated with ganaplacide plus lumefantrine solid dispersion formulation: analysis of data from KALUMI, a multinational Phase 2 study","publication_year":2026,"publication_date":"2026-11-10","ids":{"openalex":"https://openalex.org/W7225743568","doi":"https://doi.org/10.21203/rs.3.rs-11207478/v1"},"language":"en","primary_location":{"id":"doi:10.21203/rs.3.rs-11207478/v1","doi":"https://doi.org/10.21203/rs.3.rs-11207478/v1","is_oa":true,"landing_page_url":"https://doi.org/10.21203/rs.3.rs-11207478/v1","pdf_url":null,"source":{"id":"https://openalex.org/S4306525896","display_name":"Research Square","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":null,"host_organization_name":null,"host_organization_lineage":[],"host_organization_lineage_names":[],"type":"repository"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"submittedVersion","is_accepted":false,"is_published":false,"raw_source_name":"Research Square","raw_type":"posted-content"},"volume":null,"type":"preprint","is_traditional":true,"indexed_in":["crossref"],"open_access":{"is_oa":true,"oa_status":"green","oa_url":"https://doi.org/10.21203/rs.3.rs-11207478/v1","any_repository_has_fulltext":true},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5068494062","display_name":"Ramachandra Rao Sangana","orcid":"https://orcid.org/0000-0003-3772-0370","observed_orcids":["https://orcid.org/0000-0003-3772-0370"]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Ramachandra Sangana","raw_affiliation_strings":["PK Sciences, Biomedical Research"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"PK Sciences, Biomedical Research","institution_ids":[]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5083471602","display_name":"Bakary Fofana","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I4210112095","display_name":"Universit\u00e9 des Sciences, des Techniques et des Technologies de Bamako","ror":"https://ror.org/023rbaw78","country_code":"ML","type":"education","lineage":["https://openalex.org/I4210112095"]}],"countries":["ML"],"is_corresponding":false,"raw_author_name":"Bakary Fofana","raw_affiliation_strings":["University of Sciences, Techniques and Technologies of Bamako"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"University of Sciences, Techniques and Technologies of Bamako","institution_ids":["https://openalex.org/I4210112095"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5161388591","display_name":"Rella Zoleko Manego","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Rella Zoleko Manego","raw_affiliation_strings":["Centre de Recherches Medicales de BP 242"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Centre de Recherches Medicales de BP 242","institution_ids":[]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5040533373","display_name":"Sodiomon Bienvenu Sirima","orcid":"https://orcid.org/0000-0002-0972-4211","observed_orcids":["https://orcid.org/0000-0002-0972-4211"]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Sodiomon Bienvenu Sirima","raw_affiliation_strings":["Groupe de Recherche Action en Sante"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Groupe de Recherche Action en Sante","institution_ids":[]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5053245213","display_name":"Andre Offianan","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I4210138991","display_name":"Institut Pasteur de C\u00f4te d'Ivoire","ror":"https://ror.org/046p4xa68","country_code":"CI","type":"nonprofit","lineage":["https://openalex.org/I4210138991"]}],"countries":["CI"],"is_corresponding":false,"raw_author_name":"Andre Toure Offianan","raw_affiliation_strings":["Institut Pasteur de C\u00f4te d'Ivoire"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Institut Pasteur de C\u00f4te d'Ivoire","institution_ids":["https://openalex.org/I4210138991"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5005371655","display_name":"Jean\u2010Bosco Ou\u00e9draogo","orcid":"https://orcid.org/0000-0003-0412-8733","observed_orcids":["https://orcid.org/0000-0003-0412-8733"]},"institutions":[{"id":"https://openalex.org/I4210117977","display_name":"Institut d'Histoire et de Philosophie des Sciences et des Techniques","ror":"https://ror.org/02nnpw434","country_code":"FR","type":"facility","lineage":["https://openalex.org/I1294671590","https://openalex.org/I2746051580","https://openalex.org/I29607241","https://openalex.org/I4210117977","https://openalex.org/I4210150854","https://openalex.org/I51101395"]}],"countries":["FR"],"is_corresponding":false,"raw_author_name":"Jean Bosco Ouedraogo","raw_affiliation_strings":["Institut d'Histoire et de Philosophie des Sciences et des Techniques"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Institut d'Histoire et de Philosophie des Sciences et des Techniques","institution_ids":["https://openalex.org/I4210117977"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5160995161","display_name":"Mulenge Kilowele","orcid":null,"observed_orcids":[]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Mulenge Kilowele","raw_affiliation_strings":["Hopital General De Ref De Kenya"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Hopital General De Ref De Kenya","institution_ids":[]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5004530894","display_name":"Anne Claire Marrast","orcid":"https://orcid.org/0009-0001-2893-3553","observed_orcids":["https://orcid.org/0009-0001-2893-3553"]},"institutions":[{"id":"https://openalex.org/I54695851","display_name":"Medicines for Malaria Venture","ror":"https://ror.org/00p9jf779","country_code":"CH","type":"nonprofit","lineage":["https://openalex.org/I54695851"]}],"countries":["CH"],"is_corresponding":false,"raw_author_name":"Anne Claire Marrast","raw_affiliation_strings":["Medicines for Malaria Venture"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Medicines for Malaria Venture","institution_ids":["https://openalex.org/I54695851"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5161060877","display_name":"Myriam El-Gaaloul","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I54695851","display_name":"Medicines for Malaria Venture","ror":"https://ror.org/00p9jf779","country_code":"CH","type":"nonprofit","lineage":["https://openalex.org/I54695851"]}],"countries":["CH"],"is_corresponding":false,"raw_author_name":"Myriam El-Gaaloul","raw_affiliation_strings":["Medicines for Malaria Venture"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Medicines for Malaria Venture","institution_ids":["https://openalex.org/I54695851"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5005872750","display_name":"C\u00e9line Risterucci","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I1283582996","display_name":"Novartis (Switzerland)","ror":"https://ror.org/02f9zrr09","country_code":"CH","type":"company","lineage":["https://openalex.org/I1283582996"]}],"countries":["CH"],"is_corresponding":false,"raw_author_name":"Celine Risterucci","raw_affiliation_strings":["Novartis Pharma AG"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Novartis Pharma AG","institution_ids":["https://openalex.org/I1283582996"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5104147680","display_name":"Guoqin Su","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I4210117619","display_name":"Novartis (United States)","ror":"https://ror.org/028fhxy95","country_code":"US","type":"company","lineage":["https://openalex.org/I1283582996","https://openalex.org/I4210117619"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Guoqin Su","raw_affiliation_strings":["Novartis Pharmaceuticals Corporation"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Novartis Pharmaceuticals Corporation","institution_ids":["https://openalex.org/I4210117619"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5161040339","display_name":"Gen Zhu","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I4210117619","display_name":"Novartis (United States)","ror":"https://ror.org/028fhxy95","country_code":"US","type":"company","lineage":["https://openalex.org/I1283582996","https://openalex.org/I4210117619"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Gen Zhu","raw_affiliation_strings":["Novartis Pharmaceuticals Corporation"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Novartis Pharmaceuticals Corporation","institution_ids":["https://openalex.org/I4210117619"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5161092463","display_name":"Jared Thornton","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I4210129647","display_name":"Novartis (United Kingdom)","ror":"https://ror.org/039s6n838","country_code":"GB","type":"company","lineage":["https://openalex.org/I1283582996","https://openalex.org/I4210129647"]}],"countries":["GB"],"is_corresponding":false,"raw_author_name":"Jared Thornton","raw_affiliation_strings":["Novartis Pharmaceuticals UK Limited"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Novartis Pharmaceuticals UK Limited","institution_ids":["https://openalex.org/I4210129647"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5054556398","display_name":"Hira Choudhury","orcid":"https://orcid.org/0000-0002-8723-981X","observed_orcids":["https://orcid.org/0000-0002-8723-981X"]},"institutions":[{"id":"https://openalex.org/I4210090302","display_name":"Novartis (India)","ror":"https://ror.org/00dhvr506","country_code":"IN","type":"company","lineage":["https://openalex.org/I1283582996","https://openalex.org/I4210090302"]}],"countries":["IN"],"is_corresponding":false,"raw_author_name":"Hira Choudhury","raw_affiliation_strings":["PK Sciences, Novartis Healthcare Private Limited"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"PK Sciences, Novartis Healthcare Private Limited","institution_ids":["https://openalex.org/I4210090302"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5151027090","display_name":"Jayant Sancheti","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I4210090302","display_name":"Novartis (India)","ror":"https://ror.org/00dhvr506","country_code":"IN","type":"company","lineage":["https://openalex.org/I1283582996","https://openalex.org/I4210090302"]}],"countries":["IN"],"is_corresponding":false,"raw_author_name":"Jayant Sancheti","raw_affiliation_strings":["PK Sciences, Novartis Healthcare Private Limited"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"PK Sciences, Novartis Healthcare Private Limited","institution_ids":["https://openalex.org/I4210090302"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5008733303","display_name":"Cornelis Winnips","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I1283582996","display_name":"Novartis (Switzerland)","ror":"https://ror.org/02f9zrr09","country_code":"CH","type":"company","lineage":["https://openalex.org/I1283582996"]}],"countries":["CH"],"is_corresponding":false,"raw_author_name":"Cornelis Winnips","raw_affiliation_strings":["Novartis Pharma AG"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Novartis Pharma AG","institution_ids":["https://openalex.org/I1283582996"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5109311427","display_name":"Issaka Sagara","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I4210112095","display_name":"Universit\u00e9 des Sciences, des Techniques et des Technologies de Bamako","ror":"https://ror.org/023rbaw78","country_code":"ML","type":"education","lineage":["https://openalex.org/I4210112095"]}],"countries":["ML"],"is_corresponding":false,"raw_author_name":"Issaka Sagara","raw_affiliation_strings":["University of Sciences, Techniques and Technologies of Bamako"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"University of Sciences, Techniques and Technologies of Bamako","institution_ids":["https://openalex.org/I4210112095"]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5069014609","display_name":"Zhiyan Qian","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I1283582996","display_name":"Novartis (Switzerland)","ror":"https://ror.org/02f9zrr09","country_code":"CH","type":"company","lineage":["https://openalex.org/I1283582996"]}],"countries":["CH"],"is_corresponding":false,"raw_author_name":"Zhiyan Qian","raw_affiliation_strings":["Novartis Pharma AG"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Novartis Pharma AG","institution_ids":["https://openalex.org/I1283582996"]}]}],"institutions":[],"countries_distinct_count":7,"institutions_distinct_count":8,"corresponding_author_ids":[],"corresponding_institution_ids":[],"apc_list":null,"apc_paid":null,"fwci":null,"has_fulltext":false,"cited_by_count":0,"citation_normalized_percentile":null,"cited_by_percentile_year":null,"biblio":{"volume":null,"issue":null,"first_page":null,"last_page":null},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T10091","display_name":"Malaria Research and Control","score":0.9945999979972839,"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"}},"topics":[{"id":"https://openalex.org/T10091","display_name":"Malaria Research and Control","score":0.9945999979972839,"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"}},{"id":"https://openalex.org/T12547","display_name":"Pharmaceutical studies and practices","score":0.003100000089034438,"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/T11036","display_name":"Antibiotics Pharmacokinetics and Efficacy","score":0.000699999975040555,"subfield":{"id":"https://openalex.org/subfields/2736","display_name":"Pharmacology (medical)"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}}],"keywords":[],"concepts":[{"id":"https://openalex.org/C2780780316","wikidata":"https://www.wikidata.org/wiki/Q904464","display_name":"Lumefantrine","level":5,"score":0.8973000049591064},{"id":"https://openalex.org/C112705442","wikidata":"https://www.wikidata.org/wiki/Q323936","display_name":"Pharmacokinetics","level":2,"score":0.8330000042915344},{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.8090000152587891},{"id":"https://openalex.org/C2778629330","wikidata":"https://www.wikidata.org/wiki/Q904464","display_name":"Artemether/lumefantrine","level":5,"score":0.7056999802589417},{"id":"https://openalex.org/C2781413609","wikidata":"https://www.wikidata.org/wiki/Q7308373","display_name":"Regimen","level":2,"score":0.6514999866485596},{"id":"https://openalex.org/C2778371730","wikidata":"https://www.wikidata.org/wiki/Q311383","display_name":"Plasmodium falciparum","level":3,"score":0.5400000214576721},{"id":"https://openalex.org/C2908647359","wikidata":"https://www.wikidata.org/wiki/Q2625603","display_name":"Population","level":2,"score":0.47909998893737793},{"id":"https://openalex.org/C2778048844","wikidata":"https://www.wikidata.org/wiki/Q12156","display_name":"Malaria","level":2,"score":0.42340001463890076},{"id":"https://openalex.org/C126322002","wikidata":"https://www.wikidata.org/wiki/Q11180","display_name":"Internal medicine","level":1,"score":0.3986999988555908},{"id":"https://openalex.org/C98274493","wikidata":"https://www.wikidata.org/wiki/Q128406","display_name":"Pharmacology","level":1,"score":0.37209999561309814},{"id":"https://openalex.org/C76318530","wikidata":"https://www.wikidata.org/wiki/Q16833590","display_name":"Area under the curve","level":2,"score":0.3330000042915344},{"id":"https://openalex.org/C90924648","wikidata":"https://www.wikidata.org/wiki/Q120569","display_name":"Gastroenterology","level":1,"score":0.32179999351501465},{"id":"https://openalex.org/C44249647","wikidata":"https://www.wikidata.org/wiki/Q208498","display_name":"Confidence interval","level":2,"score":0.30959999561309814},{"id":"https://openalex.org/C2776999253","wikidata":"https://www.wikidata.org/wiki/Q1304270","display_name":"Combination therapy","level":2,"score":0.2948000133037567},{"id":"https://openalex.org/C31760486","wikidata":"https://www.wikidata.org/wiki/Q7180990","display_name":"Phases of clinical research","level":3,"score":0.2741999924182892},{"id":"https://openalex.org/C141071460","wikidata":"https://www.wikidata.org/wiki/Q40821","display_name":"Surgery","level":1,"score":0.2678999900817871},{"id":"https://openalex.org/C2780035454","wikidata":"https://www.wikidata.org/wiki/Q8386","display_name":"Drug","level":2,"score":0.2678000032901764},{"id":"https://openalex.org/C147583825","wikidata":"https://www.wikidata.org/wiki/Q620876","display_name":"Body weight","level":2,"score":0.26170000433921814},{"id":"https://openalex.org/C197934379","wikidata":"https://www.wikidata.org/wiki/Q2047938","display_name":"Adverse effect","level":2,"score":0.25940001010894775},{"id":"https://openalex.org/C500440147","wikidata":"https://www.wikidata.org/wiki/Q701216","display_name":"Pharmacotherapy","level":2,"score":0.25220000743865967}],"mesh":[],"locations_count":1,"locations":[{"id":"doi:10.21203/rs.3.rs-11207478/v1","doi":"https://doi.org/10.21203/rs.3.rs-11207478/v1","is_oa":true,"landing_page_url":"https://doi.org/10.21203/rs.3.rs-11207478/v1","pdf_url":null,"source":{"id":"https://openalex.org/S4306525896","display_name":"Research Square","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":null,"host_organization_name":null,"host_organization_lineage":[],"host_organization_lineage_names":[],"type":"repository"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"submittedVersion","is_accepted":false,"is_published":false,"raw_source_name":"Research Square","raw_type":"posted-content"}],"best_oa_location":{"id":"doi:10.21203/rs.3.rs-11207478/v1","doi":"https://doi.org/10.21203/rs.3.rs-11207478/v1","is_oa":true,"landing_page_url":"https://doi.org/10.21203/rs.3.rs-11207478/v1","pdf_url":null,"source":{"id":"https://openalex.org/S4306525896","display_name":"Research Square","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":null,"host_organization_name":null,"host_organization_lineage":[],"host_organization_lineage_names":[],"type":"repository"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"submittedVersion","is_accepted":false,"is_published":false,"raw_source_name":"Research Square","raw_type":"posted-content"},"sustainable_development_goals":[],"study_designs":[],"awards":[],"funders":[],"has_content":{"grobid_xml":false,"pdf":false},"content_urls":null,"referenced_works_count":16,"referenced_works":["https://openalex.org/W1587707825","https://openalex.org/W2027630305","https://openalex.org/W2039639971","https://openalex.org/W2064949809","https://openalex.org/W2082019450","https://openalex.org/W2117800297","https://openalex.org/W2135797423","https://openalex.org/W2277329615","https://openalex.org/W2318943795","https://openalex.org/W2499443985","https://openalex.org/W2892371760","https://openalex.org/W3015893846","https://openalex.org/W4242588288","https://openalex.org/W4380742864","https://openalex.org/W4402999330","https://openalex.org/W4415841317"],"related_works":[],"abstract_inverted_index":{"Abstract":[0],"Background":[1],"The":[2,176,333],"new":[3],"antimalarial":[4],"combination":[5,135],"ganaplacide":[6,137,177,262,283],"plus":[7,140,178,263,286,308],"lumefantrine-SDF":[8,179,264,287,309],"was":[9,182,209,258],"shown":[10],"in":[11,22,29,68,89,245,260,270,279,300,325],"a":[12,44,133,150,301,314],"previous":[13,302],"phase":[14,46,86],"2":[15,35,47,74,87,98,118],"study":[16,88,334],"to":[17,51,62,73,99,116,132,194,277],"be":[18],"effective":[19,322],"and":[20,32,56,61,66,113,228,238,253,340],"well-tolerated":[21],"the":[23,53,205,261,267],"treatment":[24,180],"of":[25,95,136,190],"uncomplicated":[26,78,90,328],"falciparum":[27,79,91,329],"malaria":[28],"adults,":[30],"adolescents":[31],"children":[33,69],"\u2265":[34,105,122],"years":[36,75,197],"old.":[37],"Here":[38],"we":[39],"report":[40,201],"pharmacokinetic":[41,202],"data":[42,186,203],"from":[43,187,204],"second":[45],"study,":[48],"which":[49],"aimed":[50],"optimize":[52],"dose":[54],"regimen":[55,181],"food":[57],"intake":[58],"with":[59,76,149,282,313,327,337],"dosing,":[60],"assess":[63],"efficacy,":[64],"safety":[65],"pharmacokinetics":[67],"aged":[70,97,192],"6":[71,114],"months":[72,115],"acute":[77],"malaria.":[80,330],"Methods":[81],"In":[82],"this":[83],"randomized,":[84],"open-label":[85],"malaria,":[92],"sequential":[93],"cohorts":[94,189,247],"patients":[96,191,280,326],"<":[100,117,195],"12":[101,193],"years,":[102,119],"body":[103,120,173,293],"weight":[104,121,174,294],"10":[106],"kg":[107,124],"(Cohort":[108,125],"1,":[109],"N":[110,127],"=":[111,128],"140),":[112],"5":[123],"2,":[126],"80)":[129],"were":[130,170,213,231,241,275],"randomized":[131],"loose":[134],"400":[138,284,306],"mg":[139,285,289,307,311],"lumefantrine":[141,239],"solid":[142],"dispersion":[143],"formulation":[144],"(SDF)":[145],"480":[146,310],"mg,":[147],"administered":[148],"light":[151,315],"meal":[152,316],"(100\u2013300":[153],"calories,":[154],"5-10g":[155],"fat)":[156],"q.d.":[157,317],"for":[158,318],"3":[159,164,319],"days,":[160,165],"or":[161],"artemether-lumefantrine":[162,268],"(b.i.d.":[163],"per":[166],"prescribing":[167],"information).":[168],"Doses":[169],"adjusted":[171,291],"by":[172,215,250,292],"range.":[175],"selected":[183],"based":[184],"on":[185],"run-in":[188],"18":[196],"(reported":[198],"separately).":[199],"We":[200],"study.":[206,303],"Sparse":[207],"sampling":[208],"used.":[210],"Drug":[211,273],"concentrations":[212],"determined":[214,232],"liquid":[216],"chromatography-mass":[217],"spectrometry.":[218],"Pharmacokinetic":[219],"parameters":[220],"including":[221],"AUC":[222],"0\u221224":[223],",":[224,227],"C":[225,229,256],"max":[226],"168h":[230,257],"using":[233],"non-compartmental":[234],"analysis.":[235],"Results":[236],"Ganaplacide":[237,305],"exposures":[240,274,324],"within":[242],"targeted":[243],"ranges":[244],"both":[246,271],"as":[248],"confirmed":[249],"good":[251],"efficacy":[252],"safety.":[254],"Lumefantrine":[255],"higher":[259],"group":[265,269],"than":[266],"cohorts.":[272],"comparable":[276],"those":[278],"treated":[281],"960":[288],"(doses":[290],"range)":[295],"given":[296,312],"under":[297],"fasted":[298],"conditions":[299],"Conclusions":[304],"days":[320],"achieved":[321],"drug":[323],"Trial":[331],"registration":[332],"is":[335],"registered":[336],"EudraCT":[338],"(2021-003583-27)":[339],"ClinicalTrials.gov":[341],"(NCT04546633).":[342]},"counts_by_year":[],"updated_date":"2026-11-11T12:16:26.678958","created_date":"2026-11-11T00:00:00"}
