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In fasted subjects, formulation AH lamivudine exposure was similar to the reference; however, dolutegravir exposure was consistently higher in formulation AH, with area under the concentration\u2010time curve (AUC) and maximum concentration (C<jats:sub>max<\/jats:sub>) approximately 27% to 28% greater than reference. Formulation AK met bioequivalence standards to the reference for dolutegravir (AUC<jats:sub>0\u2010\u221e<\/jats:sub> and C<jats:sub>max<\/jats:sub>) and lamivudine (AUC<jats:sub>0\u2010\u221e<\/jats:sub> and AUC<jats:sub>0\u2010t<\/jats:sub>) exposure; however, dolutegravir AUC<jats:sub>0\u2010t<\/jats:sub> and lamivudine C<jats:sub>max<\/jats:sub> were approximately 16% and 32% higher than the reference, respectively. A high\u2010fat meal increased dolutegravir AUC and C<jats:sub>max<\/jats:sub> by up to 33% and 21%, respectively, and decreased lamivudine C<jats:sub>max<\/jats:sub> by approximately 30%. Both test and reference formulations were well tolerated. The results support further development of formulation AK as a novel, 2\u2010drug, fixed\u2010dose combination tablet treatment for patients with HIV.<\/jats:p>","DOI":"10.1002\/cpdd.740","type":"journal-article","created":{"date-parts":[[2019,11,14]],"date-time":"2019-11-14T09:35:49Z","timestamp":1573724149000},"page":"189-202","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":9,"title":["Bioequivalence and Food Effect Assessment of 2 Fixed\u2010Dose Combination Formulations of Dolutegravir and Lamivudine"],"prefix":"10.1002","volume":"9","author":[{"given":"Teodora Pene","family":"Dumitrescu","sequence":"first","affiliation":[{"name":"Clinical Pharmacology Modeling and Simulation GlaxoSmithKline  Collegeville Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kavita","family":"Peddiraju","sequence":"additional","affiliation":[{"name":"Pharma R&amp;D GlaxoSmithKline  Collegeville Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Caifeng","family":"Fu","sequence":"additional","affiliation":[{"name":"PAREXEL International  Durham North Carolina USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kalpana","family":"Bakshi","sequence":"additional","affiliation":[{"name":"Pharma R&amp;D GlaxoSmithKline  Collegeville Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shui","family":"Yu","sequence":"additional","affiliation":[{"name":"PAREXEL International  Durham North Carolina USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zhiping","family":"Zhang","sequence":"additional","affiliation":[{"name":"PAREXEL International  Durham North Carolina USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Allan R.","family":"Tenorio","sequence":"additional","affiliation":[{"name":"Clinical Development ViiV Healthcare  Durham North Carolina USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chris","family":"Spancake","sequence":"additional","affiliation":[{"name":"Medicinal Science and Technology GlaxoSmithKline  Collegeville Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shashidhar","family":"Joshi","sequence":"additional","affiliation":[{"name":"Biostatistics GlaxoSmithKline India  Mumbai India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Allen","family":"Wolstenholme","sequence":"additional","affiliation":[{"name":"Pharma R&amp;D GlaxoSmithKline  Collegeville Pennsylvania USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kimberly","family":"Adkison","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology ViiV Healthcare  Durham North Carolina USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2019,11,14]]},"reference":[{"key":"e_1_2_7_2_1","unstructured":"US Department of Health and Human Services.Guidelines for the use of antiretroviral agents in adults and adolescents living with HIV.2018.https:\/\/aidsinfo.nih.gov\/contentfiles\/lvguidelines\/adultandadolescentgl.pdf. 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